Clinical Update
the mild procedure
The mild® procedure allows percutaneous, image-guided treatment of LSS by accessing the interlaminar space, concurrently removing tissue and bone to decompress the spine, and thereby potentially alleviating the symptoms associated with LSS.
The minimally invasive nature of the mild® procedure enables shorter in-patient therapy and recovery in contrast to other treatment options such as Laminotomy (open surgical), Laminectomy (open surgical) and Spinal Fusion. Patients undergoing a mild® procedure are typically discharged the following day.
the mild opportunity
mild fills an important void along the LSS treatment continuum, providing a viable option for failed ESI patients and those concerned about the invasiveness of Laminotomy and Laminectomy.
the proof is in the results
mild clinical experience: n=30
This Clinical Experience Report is intended to provide you with a summary of the early patients treated using the mild® procedure. Though not part of a controlled clinical trial, we believe the data reflect the positive benefits of this unique approach. No device-related adverse events were reported in the nearly 100 patients as of January, 2009.
physician self-reported patient demographic information – 6 weeks postoperatively
- Information consists of a 30-patient population that had physician-monitored VAS and ODI scores preoperatively and postoperatively.
- Five physicians at five different facilities contributed this information.
- Post-op scores that were entered into the calculations are the latest information obtained at least 6 weeks post-procedure.
less pain, more mobility continues
clinical strategy
Vertos Medical, Inc. is committed to the safety and effectiveness of the mild® procedure and to building clinically and scientifically relevant data collected through Institutional Review Board (IRB) governed clinical trials. The company is currently enrolling the first phase of what we anticipate to be a four-phased clinical trial. Phase I is expected to enroll 75 patients at up to 30 study centers. Adult patients with symptomatic LSS who meet the study enrollment criteria will be offered the mild® procedure as an alternative to surgery or continued standard non-surgical medical management. These patients may continue on the medical management considered appropriate by their physician/investigator. Specific inclusion criteria for the study are detailed below. A fully detailed protocol including all inclusion and exclusion information is available upon request.
Indication For Use – The Vertos mild Devices are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions. Contraindications – The Vertos mild Devices are not intended for disc procedures, rather, tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina. The Vertos mild Devices are not intended to be used near the lateral neural elements and remain dorsal to the dura using image guidance and anatomical landmarks. United States Regulatory Status – The Vertos mild Devices have received 510(k) marketing clearance from the United States Food and Drug Administration.
