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Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis

PILD for LSS is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. This procedure is generally described as a non-invasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x-ray guidance (e.g., fluoroscopic, CT) with the assistance of contrast media to identify and monitor the compressed area via epidurogram.

On January 9, 2014, CMS issued a Medicare National Coverage Determination (NCD) which allows coverage of PILD for LSS under Coverage with Evidence Development (CED) with certain conditions. The NCD that requires a prospective, randomized, controlled clinical trial (RCT) design is available on our website at http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=269.

On December 7, 2016, CMS expanded this NCD to allow coverage of PILD for LSS under CED in a prospective longitudinal study using an FDA-approved/cleared device that successfully completed a CMS-approved RCT with certain conditions. The NCD that requires a prospective longitudinal study design is available on our website at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=284.

As part of CED, we are identifying below the Medicare approved clinical trials which have been reviewed and determined to meet the requirements of coverage.

Clinical Study Approvals

Study Title: MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Sponsor: Vertos Medical
Clinicaltrials.gov Number: NCT03072927
CMS Approval Date: 02/16/2017

Study Title: A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex® Totalis™ Direct Decompression System versus a Sham Surgical Procedure in Patients with Lumbar Spinal Stenosis
Sponsor:  VertiFlex®, Inc.
Clinicaltrials.gov Number: NCT02079038
CMS Approval Date: 05/22/2014

Study Title: MILD® Percutaneous Image-Guided Lumbar Decompression versus Epidural Steroid Injections in Patients Diagnosed with Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication.
Sponsor: Vertos Medical
Clinicaltrials.gov Number: NCT02093520
CMS Approval Date: 05/06/2014

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