Technical Assessment of M.I.L.D Vertos Medical
This Technical Assessment was prepared by the AANS Emerging Technology Committee using systematic review methodology, and summarizes the findings of studies published and other publicly available information as of August 26, 2010 on M.I.L.D. by Vertos Medical. As a summary, this document does not make recommendations for or against the use of M.I.L.D. by Vertos Medical. It should not be construed as an official position of the American Association of Neurological Surgeons. Readers are encouraged to consider the information presented in this assessment and reach their own conclusions concerning the subject matter.
The American Association of Neurological Surgeons has developed and is providing this Technical Assessment as an educational tool. Patient care and treatment should always be based on a physician’s independent medical judgment given the individual patient’s clinical circumstances.
||August 26, 2010|
Aliso Viejo, CA
||Minimally Invasive Lumbar Spinal Decompression. mild devices are not intended for disc procedures but rather for tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina. These devices are not intended for use near the lateral neural elements and remain dorsal to the dura using image guidance and anatomical landmarks.|
|Cost of Device
||FDA 510(k) approval.|
||The Company was founded in 2005. There is no objective public data regarding the number of patients treated.|
||Multiple specialties have been trained in this procedure, including surgical and non-surgical providers.|
|Site of Service
||Ambulatory Surgery Center (>75%). |
||Lumbar spinal stenosis with back or leg pain |
||Using fluoroscopy, a guide wire is obliquely introduced into the facet joint. An epidurigram is preformed and the contrast identifies the dura. Dilators are placed, ending with a slender Kerrison type rongeurs and the facet/ligament is resected.|
||Deer TR, Kapural L., New Image-Guided Ultra-Minimally Invasive Lumbar Decompression Method: The mild® Procedure. Pain Physician 13:35-41, Jan/Feb2010.
This is a retrospective review of mild® procedures done by 14 treating physicians at 12 different facilities. There is no report of IRB approval, patient demographics, patient outcomes, and complications. There were no efficacy parameters collected and no adverse events were reported. The article contains a detailed description of the procedure.
Chopko B, Caraway DL. MiDAS I (mild® Decompression Alternative to Open Surgery): A Preliminary Report of a Prospective, Multi-Center Clinical Study. Pain Physician 13:369-78, July/August 2010.
This is a surgical series of 75 patients with procedures performed across a number of centers by "14 US spine specialists". Study population demographics are not included in the publication. The follow-up period was limited to six weeks. No complications of any type were reported in the series. The results showed a postoperative improvement in patients who underwent this procedure based on VAS, ODI and SF-12v2 scores compared to preop values.
||FDA approved, through the 510k process, as a bone rongeur for tissue removal. Marketing has been primarily aimed at surgeons and Pain Physicians as an alternative to other minimally invasive decompression techniques. The visualization of the intraspinal elements is based on fluoroscopic imaging and there is no direct visualization of the intraspinal contents during the course of the decompression.|
Two non-randomized publications have been reported with this device in the US literature to date. These reports represent Level III evidence in support for this device. No definitive statement can be made concerning indications, efficacy, outcomes or complications based on this literature. These publications support the potential proof of concept for this technique. Further studies are needed to establish the role for this procedure. This device is intended to permit the practitioner to decompress portions of the lumbar spinal canal through a non-traditional, fluoroscopic approach and as such the physician work, practice expense and site of service are likely to be different from those of traditional open or small incision approaches to the lumbar region.