Injections falling short? Advanced IPM practices are moving beyond epidural steroid injections (ESIs) to offer the gold standard of care for lumbar spinal stenosis (LSS) patients. Review the new data where study researchers compared the medical records of participants who had received either just one or no steroid injection prior to the mild® Procedure, to participants who received two or more epidural steroid injections prior to mild®. Similar outcomes in both treatment groups in this study proved that giving more than one ESI prior to the mild® Procedure did not improve how well patients did and may have delayed patient care. Based on the results of the study, it is recommended that the standard treatment process for LSS patients be changed to give the mild® Procedure either as soon as LSS is diagnosed or after the failure of the first ESI.

Congratulations to authors and mild® physicians Peter Pryzbylkowski, Anjum Bux, Kailash Chandwani, Vishal Khemlani, Shawn Puri, Jason Rosenberg and Harry Sukumaran for the first ever plain language article to be published in Pain Management!

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Image of article about minimally invasive direct decompression for lumbar spinal stenosis

Key Takeaways from New Data:

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mild® has been shown to provide superior clinical performance to ESIs, a similar safety profile and substantially better cost–effectiveness

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There is no clinical benefit in performing multiple ESI procedures and delaying long-lasting treatment with mild®

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Elimination of multiple ESIs and utilizing mild® immediately upon diagnosis of neurogenic claudication with hypertrophic ligamentum flavum (HLF), or after failure of the first ESI procedure is recommended as part of a modified algorithm

Take Action

  • Update your algorithm: Patients who do not experience relief after their ESI may become frustrated or lose hope. Educate LSS patients early about their care options.
  • Inform your community that you offer more: Educate patients & referral practices who are searching for alternative solutions to ESIs, pain meds, or back surgery.

The following study, “mild® Treatment Outcomes in the Presence of Foraminal Narrowing,” evaluates how the mild® Procedure outcomes for patients with hypertrophic ligamentum flavum (HLF) are impacted by the presence of concomitant foraminal narrowing. 413 patients from 11 sites were retrospectively reviewed, with VAS scores compared at baseline and follow-up (1-6 months) within each group over time and between groups. Responder rates were 76.6% for patients with foraminal narrowing, and 78.4% for patients without. Though the amount of pain improvement between groups was not significantly different, this study confirms that by debulking the HLF and reducing compression on the nerves, patients with foraminal narrowing can benefit from a relief in pressure and should not be excluded from patient selection. View the abstract poster below to learn more about the results.

Infographic: mild® Treatment Outcomes in the Presence of Foraminal Narrowing

Expand

Watch Dr. Navdeep Jassal present his abstract from the New York & New Jersey Pain Medicine Symposium 2021 Conference, where he reviews the data and shares why mild® should be considered for patients impacted by the presence of foraminal narrowing as an adjunctive spinal comorbidity.

Are you ready to put your lumbar spinal stenosis patients on the path to long-term relief? Contact Vertos Medical and discover why leading interventionalists offer mild® in their practice.

Navdeep Jassal, MD (00:00)

My name is Navdeep Jassal. I practice in Lakeland, Florida as an Interventional Pain Physician, and my primary specialty is Physiatry. I’m going to talk a little bit about a poster presentation that will be presented at the New York and New Jersey meeting, talking specifically about the mild® treatment outcomes in patients with presence of foraminal narrowing.

So the onus for this poster was to really evaluate how the mild® Procedure, how their outcomes are, for patients with not only hypertrophic ligamentum flavum, but also how, when you do this mild® Procedure, patients are impacted even with the presence of foraminal narrowing. And we obviously know that this procedure is indicated to those with patients with LSS, with neurogenic claudication, we’re going to look for the ligament. We’re going to look for at least 2.5 millimeters of hypertrophic ligamentum flavum to debulk, but we want to make sure that we understand that physicians aren’t really excluding patients with also other co-factors such as foraminal narrowing. Because oftentimes we realize when you exclude such a patient population, you’re really excluding a patient to receive an outstanding therapy that’s not only safe, but efficacious. And here we actually show a poster to show those types of results.

So we have mild® patients’ recordings that were done across 11 sites or 11 centers with outstanding colleagues. We studied 413 patients retrospectively and out of these 413 patients, we saw 302 patients with foraminal narrowing, and we saw 111 patients with no foraminal narrowing. So if you think about the data, this really shows a typical type of patient population that presents with LSS, those with not just central canal stenosis, but also patients with co-factors that presents with neuroforaminal stenosis, those with facet hypertrophy, but really we’re going to really show that patients actually present, in fact, 302, presents with foraminal narrowing. And we study these patients out, you know, 1-6 months and we followed them up from a VAS (or visual analog scale) perspective. And these were recorded and compared to their baseline findings.

(02:18) From our baseline findings, we saw that these patients typically hovered in the 8 out of 10 or a VAS score of 8 out of 10. And we saw a significant improvement, at least a drop of about 50%. So from an 8 to a 4, about 1-6 months out. What was very interesting about this data specifically, was that there was really no significant difference in terms of the responder rate between those patients that received the treatment of the mild® with those that had foraminal narrowing versus those that did not have foraminal narrowing. In fact, those that had foraminal narrowing in our study were about 76.6% that actually had the responder rate. And then 78.4% that did not have foraminal narrowing had a good responder rate as well. So you can see, there was a very similar responder rate from those that had versus those that did not have foraminal narrowing.

And so from a conclusion standpoint, I really want to make this clear that because both responder rates were similar with no significant difference between patients with or without foraminal narrowing that underwent the mild® Procedure with a significant VAS pain reduction. I really want to hit home that patients with foraminal narrowing can really benefit, from the debulkment of the ligament. And, I think the hypothesis is that when we do this decompression or posterior decompression with the mild® Procedure, we are in fact relieving pressure on the nerves in the central canal. And so again, if we go back to a simple phenomena of a small change in volume is a large change in pressure, we can see how these patients do really well. So again, really trying to hit home that those patients with foraminal narrowing should not be excluded from such a safe and efficacious procedure for their LSS with neurogenic claudication symptoms.

So I think this data is tremendous because it should help those physicians that are skeptical about treating the mild® Procedure for those patients with co-factors. I know I talk to a lot of colleagues who are questioning whether they should offer a mild® Procedure with patients with not only the LFH (ligamentum flavum hypertrophy), but with co-factors of facet hypertrophy, or foraminal stenosis. And I would really challenge them to look at the data and show that, yes you should. If patients have foraminal stenosis or foraminal narrowing, you should treat the patient with the mild® Procedure if they are following signs and symptoms of LSS with neurogenic claudication, and they fit the criteria of something that you can debulk posteriorly with the mild® Procedure. I think it’s an incredibly safe procedure. We’ve proven time and time again, that it’s efficacious from RCTs. And I think this data will challenge you to think more about utilizing the mild® therapy for these patients with LSS.

The following study, “Patients with Foraminal Narrowing Benefit from mild® Treatment” investigates procedural outcomes for mild® patients with and without foraminal narrowing as an adjunctive spinal comorbidity. Ninety-one patients from three sites were accepted for analysis and VAS scores were compared within each group over time and between groups. Responder rates were 86.4% in the group with foraminal narrowing, compared to 75.0% in the group having no foraminal narrowing. Though the amount of pain improvement between groups was not significantly different, this study confirms that lumbar spinal stenosis (LSS) patients with a narrowed foramen can benefit from the mild® Procedure and should not be excluded from treatment. View the abstract poster below to learn more about the results.

Infographic: Patients with Foraminal Narrowing Benefit from mild Treatment

Expand

Watch Dr. Denis Patterson present his abstract from the Pacific Spine & Pain Society (PSPS) 2021 Annual Conference where he reviews the data and shares why LSS patients with a narrowed foramen can benefit from mild®.

Are you ready to put your lumbar spinal stenosis patients on the path to long-term relief? Contact Vertos Medical and discover why leading interventionalists offer mild® in their practice.

Denis G. Patterson, MD (00:00)

Hey, this is Dr. Denis Patterson. I’m a physical medicine rehabilitation physician who specializes in interventional pain management. I am located in the greater Reno, Tahoe area. I’m the owner of Nevada Advanced Pain Specialists. I’ve been seeing and treating patients in the greater Reno, Tahoe area now for about 15 years, and I have to say that one of the best treatment options that I’ve had come around within the past decade has been the mild® Procedure.

Prior to this procedure, as an interventional pain physician, we’re more trying to cover up pain or, alleviate pain, but we never really could treat the underlying pathophysiology. And so it was nice that we finally got a tool in our bag of tricks to help patients that we could actually treat their underlying pathophysiology. So, a patient with wear and tear over the years, not only are they going to get a swollen disc, swollen facet joints, but the ligamentum flavum can also encroach and push into the spinal canal. And that’s what the mild® Procedure does, it allows us to have access to get between the lamina, dig out this ligamentum flavum, create a couple more millimeters of space, and in essence, probably decrease the pressure at that level in their spine and help alleviate their neurogenic claudication symptoms.

Being an advocate for this procedure, I talked to multiple physicians around the country, and one of the interesting comments that I’ve heard over the years is that, “Hey, I can give this or I can treat patients with this, but they can only have central canal stenosis.” And so to me, these physicians are looking for what I would call is a unicorn. A unicorn is a patient who has central canal stenosis only due to the ligament being hypertrophied and that’s simply not the case. When you really look back at the literature and the 2-year study that they did, the MiDAS study, what we see is only 5% of the patients in that study only had central canal stenosis. 95% of those patients had multifactorial stenosis and so that means they can have neuroforaminal stenosis, lateral recess stenosis, and central canal stenosis. And what we saw in the MiDAS study is all those patients benefited.

(02:17) But even though we have that data, over the years of training physicians in the mild® Procedure, I continue to hear, “Well they have neuroforaminal stenosis, they don’t have just central canal stenosis so, I think I’m going to pick a competitive product to treat these patients instead of the mild® Procedure.” So, from the MiDAS data that I had talked about earlier, we’d seen that patients with multifactorial stenosis benefited from the mild® Procedure. Myself, Dr. Pryzbylkowski, and Dr. Khemlani wanted to retrospectively look at patients who we had treated with the mild® Procedure and see if we could validate the results of [what] the MiDAS study had shown. And so we retrospectively reviewed 91 patients from our 3 clinics, and this went back to January of 2020. And what we found is that 32 of the patients that we had treated out of the 91 had no neuroforaminal narrowing. Meaning, they had central canal stenosis, which included ligamentum flavum hypertrophy, but they also could have had multifactorial pathology, including disc bulges and facet hypertrophy. And then the other 59 patients out of the 91, besides having multifactorial pathology, also had neuroforaminal narrowing. And then what we ended up doing is retrospectively looking at our results of these patients, who benefited from the mild® Procedure in these groups; did both groups, 1 group, or neither group benefit? And we looked at our results at one and three months after having the procedure done. And if you look under our results, we look at [how] both groups got significant pain reduction and response rates, what we see is that the foraminal narrowing group did better.

86% of these patients had a positive response rate, while only 75% of the patients that had no neuroforaminal narrowing had a pain reduction. So, when you first look at this, you think, “Oh God, this has got to be statistically significant that the foraminal narrowing group benefited more than the no foraminal narrowing group from the mild® Procedure.” But, when you really look at the “P” value, there is no statistical significance between the 2 groups. And so the conclusion that we came to, is that patients with lumbar stenosis, with neurogenic claudication, whether they have central canal stenosis only, or they have multifactorial stenosis only, both groups can benefit from having the mild® Procedure done. And so, all physicians should know that they should not exclude patients with multifactorial stenosis from having this procedure be considered.

At the American Society of Pain and Neuroscience (ASPN) 2021 meeting in Miami, several abstracts highlighted recent data that supports use of the mild® Procedure as a first line therapy. Additionally, a panel of prominent Interventional Pain Physicians convened to discuss their experiences and clinical pearls for implementing the mild® Procedure in their practices. The consensus? The abstract authors and panelists repeatedly confirmed the rationale, supporting evidence, and benefits of moving to mild® as a first line therapy for lumbar spinal stenosis (LSS).

What’s driving the MOVE2mild® among leading clinicians?

According to information presented at ASPN, mild® is continuing to be validated as an ideal procedure for LSS patients with neurogenic claudication for several key reasons:

  1. A broad base of treatable patients in pain practices and the community
  2. Refined techniques that enhance procedure efficiency
  3. Positive patient and practice impact

MOVE2mild® by recognizing LSS patient candidates in your practice

4 speakers on the panel, Drs. Navdeep Jassal, Mark Coleman, Lindsay Shroyer, and David Dickerson, each spoke to the broad patient base that is appropriate for the mild® Procedure.

Dr. Navdeep Jassal: Look for the ligament

“For percutaneous image-guided lumbar decompression, any patient with 2.5 millimeters of ligamentum flavum hypertrophy, whether they have central stenosis or lateral stenosis, is a candidate and may achieve pain relief and functional improvement…that’s where I start. The indications are very clear.”

Dr. Mark Coleman: Treat multilevel stenosis with the Streamlined Technique

“The fact that they have multilevel disease would lead you towards doing a mild®. A lot of folks were afraid of mild® because of excess radiation, but we can now do these procedures in a fraction of the time that it took in the past. Being able to treat multiple levels of stenosis opens mild® as an option for many more patients.”

Dr. Lindsay Shroyer: No limits around scoliosis

“For these procedures, positioning is everything. If you start the procedure with the patient well-positioned, you should be able to access the level you are targeting. Even if you are taking some of the ligament on the opposite side, that can produce good outcomes for the patient. So, for scoliotic curve, there’s not really a maximum or a minimum.”

Dr. David Dickerson: Focus on patients with comorbidities

“This is an elderly patient population. A lot of patients have comorbidities or may be on blood thinners that make them poor candidates for surgery. Why not start with mild®? The excellent safety profile of mild® makes it an excellent option and a procedure I offer to so many of my patients that have lumbar spinal stenosis.”

MOVE2mild® with refined techniques to enhance procedure efficiency

Clinical approaches that support delivery of the mild® Procedure faster, with less radiation, were a significant focus of the discussions at ASPN. Several leading physicians participated in a clinical study presented by Dr. Dawood Sayed that evaluated the safety and efficacy of the Streamlined Technique compared to the Standard Technique for the Percutaneous Image-Guided Lumbar Decompression (PILD) Procedure.

Image showing spinal decompression performed with a single midline incision
Image showing spinal decompression performed with a single midline incision

Their results demonstrated:

  • No significant differences in VAS scores between the 2 techniques
  • No complications with either technique

In a separate study, Dr. Navdeep Jassal and APP Christine Christensen, MSN, APRN similarly concluded that the Streamlined Technique is a more minimally invasive procedural approach for mild® and is comparable in safety to the Standard Approach, with no increased risk of serious postoperative complications to the patient. Based on this finding, they suggested mild® should be considered the first-line intervention for patients with lumbar spinal stenosis (at least 2.5 mm of hypertrophic ligamentum flavum) and neurogenic claudication after the first epidural steroid injection (ESI) fails.

Finally, Drs. Jason Pope, Timothy Deer, and Steven Falowski submitted a poster investigating the safety of using osteal landmarks instead of an epidurogram to establish a visual safety barrier prior to decompression with mild®. Based on zero complications reported across all 147 patients participating in the study, they assert that an epidurogram is not necessary for safe decompression with the mild® Procedure. Contralateral oblique view of the epidural line provides a clear view of the lamina and osteal landmarks, enabling identification of the targeted location for decompression.

X-Rays of a spine suffering from lumbar spinal stenosis
X-Rays of a spine suffering from lumbar spinal stenosis

MOVE2mild® together to drive positive patient and practice impact

Across the panel, numerous speakers highlighted the particular benefits of mild® to patients and urged early integration of mild® in the treatment algorithm.

Dr. Lindsay Shroyer: Happy patients tell their friends

mild® has completely changed the way I practice. I implement it early in my algorithm and my patients are really happy. They don’t want surgery, or may have comorbidities that mean they are not a candidate, and they are so excited about their results with mild®. They’ll go out and tell their friends and neighbors, and then we have more patients coming in asking for mild®.”

Dr. Peter Pryzbylkowski: Give patients a better quality of life

“When you start doing mild®, the word will spread like wildfire. I’ve done multiple family members who saw the results their loved ones achieved. I tell people, ‘why keep doing epidural steroid injection after epidural steroid injection?’ We know mild® has excellent safety. With mild®, we can give patients good, durable benefits that let them stand, walk, and enjoy a better quality of life.”

Dr. Jessica Jameson: Works well in multi-discipline practices

“For pain physicians in practices that include a lot of surgeons, start by picking patients who are not good surgical candidates. There are so many patients that may not be ideal for surgery or don’t want surgery that you can help. When you start there, the surgeons in your practice will see the outcomes you’re able to achieve and you can expand from there. This helps smooth the practice dynamics.”

Is your practice ready to MOVE2mild®?

For clinicians considering integrating mild® in their practice armamentarium, or practices already performing the mild® Procedure for failed serial ESI patients or patients who are not candidates for surgery, the data is clear: performing mild® early in the treatment algorithm can offer your LSS patients lasting functional improvements with a safety profile equivalent to ESIs.,

Today, an increasing number of practices recommend their patients move to mild® after the first epidural steroid injection (ESI) fails, and it’s easy to see why. mild® provides patients relief from the symptoms of lumbar spinal stenosis (LSS) and has a safety profile equivalent to an ESI, but with lasting results. In the following article, we present the most common reasons physicians and Advanced Practice Providers (APPs) are moving their patients to mild® earlier in the treatment journey.

Ready to move to mild®? Skip to the end for 3 pragmatic solutions you can implement in your practice today to get started, and get your patients on the path to relief.

5-year durability

 

A recently published study conducted by the Cleveland Clinic Study explores how many patients were able to avoid surgical decompression after the mild® Procedure over a five-year period.

The data showed that 88% of patients avoided surgical decompression for at least 5 years.

The study authors concluded that “the durability of mild® over 5 years may allow elderly patients with symptomatic lumbar spinal stenosis to avoid lumbar decompression surgery while providing significant symptomatic relief.” They also noted that “because the mild® Procedure demonstrated durability up to 5 years, it might also be speculated with caution, that appropriate patients should be encouraged to undergo the mild® Procedure as early as needed, rather than waiting until these patients are at an advanced age.”

mild® removes the problem and leaves nothing behind

No implants. mild® removes a major root cause of neurogenic claudication by debulking the hypertrophic ligamentum flavum, which reduces the compression of the nerves without leaving any implants behind.

No stitches. The entire procedure can be performed through a single, tiny incision the size of a baby aspirin (5.1mm).

Image showing how the mild® procedure does not limit future treatment options for lumbar spinal stenosis

mild® does not significantly alter the structural anatomy of the spine or eliminate future treatment options

Safety profile equivalent to an ESI

mild® offers a clinically proven safety profile equivalent to an ESI, even in patients with comorbidities.,

No device- or procedure-related serious adverse events or complications have been reported in any clinical trial.

Patients typically resume normal activity within 24 hours with no restrictions

Unlike more invasive procedures that can require a lengthy recovery, mild® patients typically resume normal activity within 24 hours with no restrictions.

mild® procedure testimonial - Nicky

“When I went for the procedure, it was any other day. I went into the procedure. You feel nothing, and then you come back and you’re fine. I mean, it’s no big deal. There’s no pain, there’s no recovery, you just go home.”

-Nicky, mild® Patient

mild® procedure testimonial - Ronnie

“By the time I walked out [after the mild® Procedure], I went home, and I could get out. The first thing I wanted to do was start doing stuff. That was a big moment in my life emotionally.”

-Ronnie, mild® Patient

Avoids Epidural Exhaustion

LSS patients who receive a series of epidural injections may become frustrated or start to lose hope if the injections provide little relief or decreasing relief over time. While ESIs can sometimes deliver transient, temporary relief, they do not address the root cause of stenosis. The mild® Procedure decompresses, debulking the hypertrophied ligament, to reduce spinal canal narrowing, giving patients a new option to achieve long-term relief.

Featured Data: Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial

Janna L. Friedly et al. studied the long-term effectiveness of ESIs for LSS and the effect of repeat injections. The trial concluded that repeated epidural injections offer no additional benefit if injections in the first 6 weeks did not improve pain.

Alexander Escobar, MD

Physician perspective: Alexander Escobar, MD

“If the patient has received ESIs in your practice and the outcomes were not efficacious, there is no reason to offer them another one. If a patient comes to you from another practice, and has recent history of epidural steroid injections, move to mild®. They’re likely seeking an alternate option, and mild® is something that can provide them hope.”

mild® procedure testimonial - Lynn

Patient perspective: Lynn, mild® Patient

“The first epidural lasted about three months and then the pain was back. I went for the second epidural, and it didn’t last two weeks. My physician said, ‘Well, you can have one more.’ I said, ‘No, I’m finished with them, I want the mild® Procedure.’”

Ready to move to mild®?

Here are a few tips to help you successfully integrate mild® into your practice.

1. Look for the ligament, it’s a common problem

Image showing hypertrophic ligamentum flavum (HLF) >= 2.5mm

When reviewing a patient’s MRIs/CTs, be sure to identify hypertrophic ligamentum flavum (HLF). HLF ≥ 2.5 mm can be readily identified and is surprisingly common, contributing to up to 85% of spinal canal narrowing.

2. Present mild® in initial ESI treatment plan

Introducing patients to mild® early in their treatment journey can help them feel assured that they have effective options if ESIs don’t provide the relief they need. Dr. Jason Pope of the Evolve Restoration Center confirms, “By presenting mild® as part of the treatment plan from the start, patients have more confidence that we are going to be proactive in their care, and make sure they have the opportunity to access advanced LSS treatment options that offer excellent outcomes.”

3. Engage APPs in patient identification and treatment planning

Many practices that offer mild® ensure that physicians and Advanced Practice Providers (APPs) alike are trained to identify patient candidates who may benefit from the mild® Procedure. Jane Hartigan, an APP in a leading Northern California pain management practice recommends asking proactive questions like, “Does hunching forward significantly relieve the pain you’re feeling?”, or “Do you feel pain in your back and legs when standing or walking?” By understanding your patient’s current experience with LSS, their treatment history, and functional goals, you can readily spot the many patients in your practice who may benefit from the mild® Procedure.

Physicians and practices treating lumbar spinal stenosis (LSS) patients with epidural steroid injections (ESIs) will likely recognize a common “condition” among serial ESI patients that our practice typically refers to as “Epidural Exhaustion.” Epidural Exhaustion is typically seen in patients who have tried multiple injections but have experienced only short-term functional improvements with little to no pain relief. Many times, LSS patients who do not improve after a single ESI or series of ESIs can become frustrated, or begin to lose hope in ever feeling relief from their spinal stenosis symptoms.

While “Epidural Exhaustion” is remarkably common among lumbar spinal stenosis (LSS) patients, it is avoidable. In our practice, we have found that moving to mild® (Minimally Invasive Lumbar Decompression) earlier in the patient journey helps drive positive long-term clinical outcomes and stronger patient satisfaction. Today, we have changed our practice workflows to move more patients to mild® after their first failed ESI. We proactively communicate the benefits of the mild® Procedure to our patients at the time of diagnosis or before they begin their treatment journey in our practice, so that they understand the breadth of their treatment options. With the availability of mild® as an early treatment option for more spinal stenosis patients, we can reduce incidences of ESI exhaustion and put more of our LSS patients on the path to long-term relief.

Challenging the status quo around serial ESIs

Although repetitive epidural steroid injections are still the standard of care in many practices and instilled during our training, the data show that serial ESIs offer little benefit to long-term patient outcomes.

As noted by Heidi Younan, Director of Patient Marketing & Practice Integration at Vertos Medical, we already know that epidurals are not capable of “curing” neurogenic claudication, which is present in 94% of patients with lumbar spinal stenosis. While repetitive ESIs deliver some chemical benefit and can offer transient, temporary relief for radicular components, ESIs do not address a major root cause of stenosis. Decompression is required to reduce narrowing/triangulation and relieve pressure in the central canal.

 

Friedly et al: “Repeated epidural injections offer no additional benefit”

 

A 2016 study conducted by Janna L. Friedly et al., studied the overall long-term effectiveness of treatment with epidural corticosteroid injections for lumbar central spinal stenosis and the effect of repeat injections on LSS patient outcomes through 12 months. The multicenter, double-blind, randomized, controlled trial with 400 patients concluded that repeated epidural injections offer no additional benefit if injections in the first 6 weeks did not improve pain. Therefore, performing multiple ESIs on patients who did not benefit from the initial injection is essentially delaying treatment that can provide beneficial and long-term outcomes.

Move to mild®: Clinical Benefits

Because of its effectiveness and safety profile, I strongly recommend moving to mild® earlier in the patient journey, after the first failed ESI. Recognizing that up to 85% of spinal canal narrowing is the result of hypertrophic ligamentum flavum (HLF), there is tremendous benefit in being able to debulk the HLF and restore space in the spinal canal, thus reducing compression of the nerves. The minimally invasive mild® Procedure enables our practice to offer a treatment option that is a step up from ESIs with the same low complication rate, but with excellent effectiveness and lasting results.

Ms. Younan also highlights that clinical studies of mild® have demonstrated clinically meaningful, statistically significant improvements in mobility, Oswestry Disability Index (ODI), and pain reduction on the numeric pain rating scale (NPRS). More recent 5-year data shows that after undergoing the mild® Procedure, only 12% of patients required surgical decompression at the same level over 5 years. Stated differently, mild® gives the potential to help 88% of patients avoid surgical decompression surgery for at least 5 years, while providing symptomatic relief during that time.

94% of lumbar spinal stenosis (LSS) patients have neurogenic claudication88% of mild procedure patients avoided surgical decompression for at least 5 years85% patient satisfaction from patients receiving the mild® procedure

Move to mild®: Practice Benefits

Beyond the individual clinical benefits, I also advise other pain specialists that there are many practice-driven reasons to offer mild® in lieu of serial epidural steroid injections. The MiDAS ENCORE level 1 data demonstrated an exceptionally high 85% patient satisfaction rate among patients who received the mild® Procedure. Patient satisfaction is a key benchmark in our practice. With the mild® Procedure, we have seen tremendous patient satisfaction, and we know that those patients tell their friends, relatives, and neighbors about their positive results, which increases word-of-mouth to our practice.

The right patient. The right treatment. The right time.

My goal as a physician is always to assess where the patient is in their treatment journey, the impact of lumbar spinal stenosis symptoms on their lifestyle, their priorities for the procedure (such as a minimally invasive approach or a short recovery time), and their treatment history to determine the best path forward for that individual.

This purpose of this article is certainly not to challenge any and all use of ESIs within the modern pain or spine practice. ESIs can be an effective tool and are a critical part of our practice armamentarium. For some patients, ESIs offer significant benefits; however, evidence and experience demonstrate that ESIs are not a one-size-fits-all solution. Many patients with LSS fail to achieve significant pain reduction, while others who do experience pain reduction or functional improvements find those benefits to have limited durability.

In our practice, we still commonly begin a lumbar spinal stenosis treatment plan with a conservative approach to determine if an ESI will effectively reduce the symptoms of LSS. Once we understand how our patient responds to an ESI, we can determine the best treatment plan for the patient. If they have a good result with an ESI, we suggest that they resume normal activities and self-monitor for changes over time. On the other hand, if they do not see significant benefit from the initial ESI, I will strongly consider them as a candidate for mild®, and barring any contraindications, we typically schedule their mild® Procedure within a few weeks.

Accelerating Our Assessment of Epidural Efficacy

A powerful message for patients looking for significant relief is that we will start their LSS treatment with an ESI, but we’ll also be able to know very quickly if the epidural steroid injection is going to be successful for them. When patients understand that they have other minimally invasive, nonsurgical options, they may be less concerned if they experience limited relief from their first ESI.

The key question is, “At what point can we reliably assess whether an individual patient will benefit from serial ESIs?” Here again, we can look to the Friedly data showing that repeated epidural injections offered no additional long-term benefit if injections in the first 6 weeks did not improve pain. Based on this data and the results we’ve seen first-hand in our own practice, we know that we can assess our LSS patient results post-ESI and determine whether we should move them to mild® earlier in their treatment journey.

Our Lumbar Spinal Stenosis Patient Workflow 

Image showing the treatment progression for patients suffering from lumbar spinal stenosis

(Graphic courtesy of Vertos Medical)

Starting with mild® in mind

One of the most significant ways our practice has shifted after the adoption of mild® is that we now evaluate most patients as potential mild® candidates. If we suspect LSS, we present mild® as a treatment option from the start. In making this shift, we have discovered a few clinical and workflow pearls that optimize success across the practice.

1. Train staff to recognize patient symptoms

Because LSS is especially common among adults over 60 years of age, and our practice treats a high volume of senior patients, we have found that many of our existing and new patients are excellent candidates for mild®.

Our practice trains our APPs and other support staff so they can immediately recognize the signs and symptoms of LSS independently. Of course, we ultimately diagnose LSS and neurogenic claudication with the support of imaging, but I always remind our staff and patients that imaging can’t show pain. As a healthcare team, we need to be proactively asking questions like, “Does hunching forward significantly relieve the pain you’re feeling?” or “Do you feel pain in your back and legs when standing or walking?” If the answer to either question is yes, we know there’s a good chance that patient may be candidate for mild®.

Younan also notes that the Vertos team has developed resources and training to support APPs. All resources are available through your Vertos sales representative.

2. Look for the ligament

When reviewing a patient’s MRIs/CTs, a simple rule we use is “look for the ligament.” Hypertrophic ligamentum flavum is a common problem that contributes up to 85% of spinal canal narrowing. We have trained our APPs to apply this rule while reviewing images to help identify patients who may benefit from the mild® Procedure.

Image showing thickened ligament, resulting in compression of the spinal cord nerves.

In the image, the thickened ligament can be seen clearly, resulting in compression of the spinal cord nerves.

3. Present mild® in your initial LSS treatment plan

When we work with patients, we make sure they know that our focus is on improving their functionality and reducing pain. We are clear from the start that we’re going to evaluate their symptoms, treatment history, and goals to determine their best treatment pathway based on the latest evidence and techniques.

Patients are generally open to the idea that a therapy that works for one patient might not work for them. So, I typically tell the patient, “We are going to start with a single epidural, and we’ll be able to know quickly if the epidural is going to be effective for you.” I also let them know that if they do not experience a significant improvement after the epidural, or if those results wear off after a short period, we can still help them with proven, minimally invasive options. Then, I tell them about the mild® Procedure, and how it offers a safety profile similar to an epidural, but with lasting results.

By presenting mild® as part of the treatment plan from the start, patients have more confidence that we are going to be proactive in their care and make sure they have the opportunity to access advanced LSS treatment options that offer excellent outcomes.

Overall, the addition of mild® has been a real game-changer in our practice. We see mild® as a safe and effective alternative to serial ESIs that drive long-term patient improvements and high patient satisfaction—a treatment we make available to as many patients as possible, as early as possible. I regularly tell other interventional pain specialists to incorporate mild® in their practice, and once they see the impact it has on their patients, they understand why we are so passionate about moving to mild® after failure of the first ESI.


About Dr. Jason Pope

Jason Pope, M.D. - Interventional Pain Physician trained in Pain Medicine at the Cleveland ClinicJason Pope, MD, is an Interventional Pain Physician trained in Pain Medicine at the Cleveland Clinic with board certifications in Anesthesia and Pain Medicine. He completed an Anesthesiology Residency at Vanderbilt University Medical Center and received his medical degree from the Indiana University School of Medicine. Dr. Pope is the Founder and CEO of Evolve Restorative Center in Northern California and serves as an expert reviewer for the Medical Board of California. Dr. Pope also serves as President Emeritus and Chairman for the Pacific Spine & Pain Society (PSPS), President Elect for the American Society of Pain & Neuroscience (ASPN), Director at Large and Chairman for the International Neuromodulation Society (INS), and Chairman for the North American Neuromodulation Society (NANS).

About Heidi Younan

Heidi Younan - Director of Patient Marketing & Practice Integration at Vertos MedicalHeidi Younan is the Director of Patient Marketing & Practice Integration at Vertos Medical. A critical member of the Vertos team for over a decade, Ms. Younan works with clinicians, APPs, and patients to support the successful integration of the mild® Procedure in pain practices and help more patients experience the life-changing benefits of mild®. Ms. Younan also contributed portions of the clinical content within this article.

The objective of the study “Use of Epidurogram is Not Necessary for Safe, Minimally Invasive Direct Lumbar Decompression” was to investigate the safety of using osteal landmarks vs an epidurogram to establish a visual safety barrier prior to decompression with the mild® Procedure. A retrospective data analysis was performed on 147 patients that compared those receiving an epidurogram with performance of the mild® Procedure versus those that did not. View the abstract poster below to learn more about the outcomes.

Infographic showing the objective, methods and results of how the Use of Epidurogram is Not Necessary for Safe, Minimally Invasive Direct Lumbar Decompression

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Watch Dr. Jason Pope present his abstract from the American Society of Pain and Neuroscience’s (ASPN) Third Annual Conference where he shares why the use of an epidurogram is not necessary for safe decompression with the mild® Procedure.

Eager to further understand the mild® Procedure and how it can put your lumbar spinal stenosis patients on the path to long-term relief? Contact Vertos Medical and discover why leading interventionalists offer mild® in their practice.

This study was recently published in the Journal of Pain Research, click here to view.

Jason Pope, MD (00:00)

Well, welcome everyone. My name is Dr. Jason Pope. I have a practice in Northern California serving Napa, Sonoma, Mendocino counties and I’m here today to talk a little bit about an innovative strategy that we had in performing the mild® Procedure. And the question that we were trying to answer with this was essentially, “Is the epidurogram necessary when executing the mild® Procedure on patients, whether you’re going to perform a single level or a multilevel strategy?” And so we retrospectively looked at 147 patients. So we can see here the female to male breakdown along with a median age of around 77. And we looked at patients that either got the epidurogram with performance of the mild® [Procedure] versus those that did not. And we did so equitably across the patient population that we were serving. And as we can see with a stenotic level, clearly the most common areas that were performed were at L3-4 and L4-5 and that’s no surprise. And then we looked at patients whether they were done as a single level or a multilevel. And we can see here that the breakdown of these patients where 54 patients received contrast, 42 non-contrast, in a single level. And the most common level that was performed was at L4-5. But what was also very interesting was in this retrospective review, again, of about 147 patients, about 80% of them had the procedure done bilaterally if it was at a single level. And interestingly enough, when we did a multilevel mild®, and in this cohort, it represented at least two levels, the most common level that was the index level of where it was treated was at L3-4 and bilaterally, this was performed nearly 50% of the time. So when people do multiple levels of [the] mild® Procedure, the unilateral reality based on symptoms changes a little bit as compared to if you were doing a single level.

(02:27) And again, this was done over a total cohort of 147 patients. And the way that this came about and again, we highlighted the fact that when we looked at the use of epidurogram in managing patients with spinal stenosis symptomatically, with the mild® Procedure, it wasn’t clear that it really offered an increase in safety. And it wasn’t clear that it highlighted when the decompression was completed because epidural flow after decompression doesn’t necessarily increase after the ligament is trimmed or resected. So we looked at trying to simplify the procedure, and this was done just by using the osteal landmarks. And we can see the facet line and the laminar line in the middle section of the abstract presentation here. And I can say with confidence, using osteal landmarks alone as compared to the epidurogram, and we use the midline incision, the refined Streamlined Technique that you all have come to know and love, that in performing this, there were zero complications, as defined as problems with infection, nerve injury, allergy to contrast, which is something that can happen, but clearly in this cohort, it did not.

And so there were zero complications performing either one level or multilevel [mild®], either unilaterally or bilaterally with contrast or without contrast. So this underscores the importance and the strategy that if one chooses or elects to not use the epidurogram in performance of the mild® [Procedure] you can do so safely, based on this patient cohort. So again, appreciate your time. I want to also thank my co-authors associated with this project, Dr. Timothy Deer and Dr. Steven Falowski. And I want to also thank the Vertos team for helping with the assembly of the abstract. So with that, thank you.

The objective of “Minimally Invasive Decompression for Lumbar Spinal Stenosis: The Impact of Moving to mild® Directly or After Initial ESI Failure on Clinical Performance—A Six Center Retrospective Report” was to understand how epidural steroid injection (ESI) use prior to mild® impacts patient outcomes. In this clinical study, 145 patients were divided into 2 groups receiving either 0-1 or 2+ ESI procedures prior to mild®. View the abstract poster below to discover the results of the retrospective report and learn why moving to mild® after the first ESI fails can put more spinal stenosis patients on the path to long-term relief.

Infographic showing objective, methods and results of minimally invasive lumbar decompression for lumbar spinal stenosis

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Watch Dr. Peter Pryzbylkowski present his abstract from the American Society of Pain and Neuroscience’s (ASPN) Third Annual Conference in which he reviews the data and shares why he moves his lumbar spinal stenosis (LSS) patients to mild® earlier in the treatment journey.

Do you want to learn more about mild® and challenge your thinking around ESIs? Contact Vertos Medical for more information about the minimally invasive mild® Procedure and read about Dr. Jason Pope’s experience dealing with “Epidural Exhaustion” in his new blog.

Peter Pryzbylkowski, MD (00:00)

My name is Dr. Peter Pryzbylkowski. I’m a board certified anesthesiologist and board certified interventional pain specialist with the Relievus Pain Management Group, based out of the Philadelphia area. I want to thank Vertos, number one, for getting me involved with this study.

So, the objective of this study was to determine whether or not, no epidurals, one epidural versus a series of epidurals, made any difference in terms of pain relief, pain reduction, post-mild® Procedure. So, this is a nice clinical study because it kind of expands the bandwidth of practices across the country.

So, we have 6 total centers, 145 patients, that was enrolled in this study. Basically it was a retrospective review of patient charts we all did, and it’s important to notice, specifically under the objective tab, that the comorbid conditions coexisting, with patients with lumbar spinal stenosis with neurogenic claudication, is noted there, so these patients had bulging discs, herniated discs, facet arthropathy, facet hypertrophy, narrowing of the foramen, degenerative disc disease, osteophytes, and other comorbid conditions, so even though these patients had other comorbid conditions that are listed there, these patients still had good clinical and durable clinical results after post decompression procedure.

So, you can see the average ages there, the breakdown of male versus female, and those comorbid conditions I had mentioned before. And the groups we’re looking at, so it’s a group of patients who either had no epidurals or one epidural, versus two or more epidurals. So 145 patients total, were looked at in this retrospective review, and we followed the results, both at the baseline pre-procedure, one week post-operatively, and 3 months after mild® Procedure was performed. And, what you can see in the results section is that multiple epidurals versus no epidurals or one epidural did not make a difference in terms of VAS scores post-mild® Procedure.

(02:13) So, really what this is telling us as pain providers, is it doesn’t matter if you do no epidurals, one epidural or multiple. It’s not gonna affect your clinical outcome post-mild® Procedure, so the take home message from a retrospective review like this is that really, doing epidurals, a series of epidurals, really, we know as pain doctors, doesn’t really provide long-term clinical benefit, and it’s not gonna affect the outcome post-lumbar decompression. So if you have a patient with lumbar spinal stenosis with neurogenic claudication, they have ligamentum flavum hypertrophy, they’re candidates for the mild® Procedure and it’s important to do the procedure sooner rather than later ’cause all you’re really doing with a series of epidurals is delaying appropriate care, so kind of the message that this has hit home in my own personal practice is, I’ve really been able to go to all my advanced providers and say, “Listen, if we have patients who are kind of stuck in this rut of doing multiple epidurals, epidural, epidural, epidural for their lumbar spinal stenosis, we should really be considering doing the mild® Procedure to help give them good long-term benefit, rather than giving them multiple injections, which increases the risk of infection, increases the risk of an untoward side-effect.” Obviously every time we do a procedure there’s always a risk.

It’s nice to do a procedure that can give them long-term benefit, so if you have patients that have spinal stenosis, it’s just important to keep in mind mild® as a first treatment step rather than treatment that you would consider down the road for patients with spinal stenosis with neurogenic claudication. So I would not delay treating these patients when they come to my clinic. So, I used to do an epidural, 2 epidurals, 3 epidurals, for patients with spinal stenosis with neurogenic claudication. The outcomes really were hit or miss, so for me personally, I’m offering these patients percutaneous decompression in the form of the mild® Procedure a lot sooner than I used to 2-3 years ago. And the data from this retrospective study kind of shows that by doing the procedure sooner rather than later, not delaying care, we can give them good long-term benefit, give them a procedure that’s actually indicated for their pathology and approved for their pathology, rather than delaying care with a series of epidurals.

The following study, “Single-Center Comparison of Streamlined Technique Safety for mild® Procedure: Measuring Incidence of Postoperative Complications Compared to Standard Approach,” evaluates the safety of the Streamlined Technique in patients treated consecutively by a single center. As the mild® Procedure has become more widespread in clinical practice, there has been an evolution from the Standard Approach to the Streamlined Technique, a less invasive procedural approach. Dr. Navdeep Jassal and Christine Christensen, MSN, APRN, of the Spine & Pain Institute of Florida, evaluated 78 mild® patients treated using either the Streamlined Technique or the Standard Approach and measured the occurrence of postoperative complications. View the abstract poster below to discover the results of this study, and learn why the mild® Procedure should be considered the first-line intervention for patients with lumbar spinal stenosis after conservative treatments have been exhausted.

Infographic showing objective, methods and results of Single-Center Comparison of Streamlined Technique Safety for mild® Procedure

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Watch Dr. Jassal and Christine Christensen present their abstract from the American Society of Pain and Neuroscience’s (ASPN) Third Annual Conference, where they discuss why the Streamlined Technique is a more minimally invasive procedural approach for the mild® Procedure and comparable to the Standard Approach in terms of its safety profile.

Eager to further understand the mild® Procedure and the technique described above? Contact Vertos Medical to learn more about the Streamlined Technique or check out the animation and physician experience from Dr. Jassal in this Procedure Evolution blog.

Navdeep Jassal, MD (00:01)

Hello, my name is Navdeep, Dr. Navdeep Jassal from the Spine Institute of Florida in Lakeland, Florida. I’m here to discuss a little bit about a study that is very meaningful to myself and especially my patients in my practice. We’re going to talk a little bit about the Streamlined Approach for the minimally invasive lumbar decompression or the mild® Procedure, and how that’s really changed the way I’ve practiced. We’re going to talk specifically about the safety profile for this particular technique and its comparison to the standard or the classical approach that we’ve used for years.

So what we did was we did a retrospective chart review on our patients and we just wanted to measure the incidence of postoperative complications of the Streamlined Technique compared to the Standard Approach. And we know that the Standard Approach is a very safe as well as an efficacious procedure, and we’ve seen this really time and time again, but classically we’ve seen this from the RCT from the MiDAS ENCORE study, which showed the approach of the Standard Approach, comparing the epidural steroid injection, which is the standard procedure that you do for patients with lumbar spinal stenosis with neurogenic claudication. And then comparing that with the mild® or the minimally invasive lumbar decompression procedure.

I wanted to take this a step further and I wanted to make sure that the complication rate was pretty much the same, which was extremely rare, comparing the Streamlined Approach with the Standard Approach and that’s simply what we did in this retrospective chart review in our practice. I’m going to turn it over to Christine Christensen, who is going to talk a little bit about the data and dive really further into the data because I think it’s just quite interesting.

Christine Christensen, MSN, APRN (02:06)

Hi, I’m Christine Christenson. I’m the Nurse Practitioner that works with Dr. Jassal here in Lakeland, Florida. As part of my practice here, Dr. Jassal was able to include me in generating data and analyzing that data for our research study here looking at the efficacy and safety of the Streamlined Technique. Now, data collection for this study consisted of reviewing charts on 78 patients that had the mild® Procedure performed for them. Dr. Jassal started doing the Streamlined Technique after certain dates.

So we looked at the date and the operative notes for those patients to verify that they did get the Streamlined Technique in the operating room. Of those patients, 100% had confirmed central spinal stenosis on MRI. They also had ligamentum flavum hypertrophy, degenerative disc disease with disc bulges, and facet arthropathy. Of the 78 patients, 97% had concurrent foraminal stenosis. So when we broke that down to the patients who had the Streamlined Technique after Dr. Jassal was trained in proper performance of the technique, we had 44 “streamlined” patients and then 34 patients who had the Standard Approach for the mild® Procedure.

So we took the 44 patients with the Streamlined Technique and the 34 Standard Approach patients and compared occurrence of postoperative complications, including reoperation, device- and procedure-related AEs, serious AEs, and lumbar spine fractures. We also did include removal of hardware, although we do know a big pro of the mild® Procedure is that there is no hardware placed into the patient, really maximizing patient benefit and minimizing risks for patients. This study did show that the Streamlined Technique did not have any increase in risk for patients versus the Standard Approach.

Navdeep Jassal, MD (04:13):

So in conclusion with our study, the Streamlined Technique is a more minimally invasive procedural approach for the mild® Procedure and it’s even comparable in terms of safety profile to the Standard Technique or the Standard Approach. There’s really no increased risk of serious postoperative complications to the patients. And we know that it’s comparable to the data that was shown in the ENCORE study or the RCT in the past.

Also, the mild® Procedure should be considered first-line intervention for patients with lumbar spinal stenosis, with neurogenic claudication symptoms, in a state where they know that they have at least 2.5 millimeters of ligamentum flavum on an MRI exam or a CAT scan study. So really they should be considered first-line intervention after conservative therapy is tried and even after the first epidural steroid injection is completed for your patient.


About Dr. Navdeep Jassal

Dr. Navdeep Jassal, M.D. Navdeep Jassal, MD, is a Physiatrist and Interventional Pain Physician with a Fellowship in Pain Medicine from University of South Florida Morsani College of Medicine and board certifications in Pain Medicine and Physical Medicine and Rehabilitation. He completed a Residency in Physical Medicine and Rehabilitation at the Zucker School of Medicine at Hofstra/Northwell and received his Doctor of Medicine from Ross University School of Medicine. Dr. Jassal currently serves as an Assistant Professor for the Department of Physical Medicine & Rehabilitation at the University of Central Florida as well as an Assistant Clinical Professor for the University of South Florida’s Pain Medicine Fellowship program. Dr. Jassal is the Young Guys Co-chair for the American Society of Pain & Neuroscience (ASPN), Secretary for the Florida Society of Pain & Neuroscience (FSPN) and Section Editor for the Pain Physician Journal. He holds memberships with the American Society of Interventional Pain Physicians (ASIPP), Florida Medical Association (FMA), North American Neuromodulation Society (NANS), International Neuromodulation Society (INS), Florida Association of Physicians of Indian Origin (FAPI) and Association of Academic Physiatrists.

 

About Christine Christensen, MSN, APRN

Christine Christensen, MSN, APRN

Christine Christensen is a Nurse Practitioner who works as an Advance Practice Provider at the Spine & Pain Institute of Florida and partners closely with Dr. Navdeep Jassal. She completed her Bachelor of Science in Neuroscience at Brigham Young University. Christine then earned a Bachelor of Science in Nursing from the University of North Carolina at Chapel Hill and earned her Master of Science in Nursing at the University of Alabama at Birmingham.

 

The following study, “Evaluation of Safety and Efficacy of the Streamlined Technique vs the Standard Technique for Accessing Decompression Treatment Zones for the PILD Procedure,” investigates the safety and efficacy of the Streamlined Technique compared to the Standard Technique. While the PILD, or mild® Procedure, may be performed using both methods, the Streamlined Technique enables a single midline incision to access multiple treatment zones whereas the Standard Technique uses one incision per treatment zone. The study involved 243 patients that underwent the mild® Procedure using either technique and tracked their outcomes. The authors concluded that the Streamlined Technique does not compromise the safety or efficacy of the mild® Procedure. View the abstract poster below to learn why the Streamlined Technique is an innovative approach to consider.

Infographic showing objective, methods and results of Evaluation of Safety and Efficacy of the Streamlined Technique vs the Standard Technique

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Watch Dr. Dawood Sayed present his abstract from the American Society of Pain and Neuroscience’s (ASPN) Third Annual Conference, where he discusses how the study found that adopting the Streamlined Technique allowed for efficient and effective decompression of multiple treatment zones, without compromising the safety or efficacy of the mild® Procedure.

Eager to further understand the mild® Procedure and the technique described above? Contact Vertos Medical to learn more about the Streamlined Technique or check out the animation and physician experience from Dr. Navdeep Jassal in this Procedure Evolution blog.

Dawood Sayed, MD (00:00)
Hello, I’m Dr. Dawood Sayed and I’m a Professor of Anesthesiology and Pain Medicine at the University of Kansas. Today on behalf of my co-investigators, I’m gonna be presenting our abstract, an “Evaluation of the Safety and Efficacy of the Streamlined Technique vs the Standard Technique for Accessing Decompression Treatment Zones for the Percutaneous Interlaminar Lumbar Decompression (PILD) Procedure.” Our objectives were to investigate the safety and efficacy of the Streamlined Technique compared to the Standard Technique for the percutaneous image guided lumbar decompressive procedure. In summary, the Streamlined Technique is a single midline incision to access multiple treatment zones versus the more traditional standard techniques, in which multiple incisions are made to access multiple treatments zones. It was the hypothesis of the investigators, that using the Streamlined Technique, that we would be able to perform the procedure in an equal satisfactory manner with the same efficacy, but also performing the procedure in a much less invasive manner for the patient.

(01:03) So our methods were 243 patients with a baseline visual analog score of greater than five. These patients underwent the PILD Procedure at 1 or 2 treatment levels using either the Streamlined Technique which is about 136 patients, or the Standard Technique, which was about 107 patients. If you look at the table here, you can see that most of the patients were treated at either the L-3, L-4 or the L-4, L-5 levels. And again, the Streamlined Technique is a decompression performed using a single midline incision. The technique involves pulling back the portal to the subcutaneous tissue, and triggering tissue to change the level or side of treatment, to access and decompress multiple treatment zones through a single incision. When we look at our results, you can see the average pain level was around an 8 on a VAS mean score. When you look at the immediate pain relief and efficacy at around 2 weeks, you can see that the difference between the results and efficacy between the Standard Technique and the Streamlined Technique was almost identical. When you look at these patients a little further out at 1 to 3 months, again, you can see no difference in the outcomes in pain scores, as well as complication rates between the two arms when comparing the Streamlined and Standard Technique. So in conclusion, the Streamlined Technique does not compromise safety or efficacy of the PILD Procedure. We look forward to evaluating this in a more prospective, rigorous manner, to evaluate it as a true change in the way we do this procedure. Thank you.

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