CMS Provides Coverage for VertiFlex Technology to Treat Spinal Stenosis

The Centers for Medicare & Medicaid Services (CMS) now will provide reimbursement coverage for spinal stenosis treatment technology from VertiFlex Inc. CMS issued its final decision for Percutaneous Image Guided Lumbar Decompression (PILD) for spinal stenosis, allowing coverage with evidence development (CED).

Under this decision, Medicare coverage for the VertiFlex Totalis Direct Decompression System will be available for beneficiaries with lumbar spinal stenosis (LSS) who are enrolled in an approved CED clinical study.

“We are very pleased with the decision of CMS to allow CED for this very promising technology,” said Earl R. Fender, president and CEO of the San Clemente, Calif.-based firm. “There now exists a pathway for reimbursement for PILD procedures and Totalis for Medicare beneficiaries. We appreciate CMS’ leadership in allowing coverage with evidence development, and look forward to working with them to finalize a robust clinical trial protocol.”

The Totalis Direct Decompression System is a set surgical instruments designed to perform minimally invasive decompression of the lumbar spine. Totalis uses the VertiFlex interspinous access platform to treat spinal conditions such as lumbar stenosis. The procedure involves a small working cannula about the size of a dime, providing physicians the ability to remove targeted ligament, bone and facet capsule material. This broad decompression involves minimal collateral tissue disruption and can be performed under local anesthesia. The Totalis System was 510(k) cleared by the U.S. Food and Drug Administration in November 2012.

“The Totalis procedure has been a great addition to my practice,” said Timothy Davis, M.D., medical director of Orthopedic Pain Specialists in Santa Monica, Calif. “I am now able to offer spinal stenosis patients, who are unresponsive to conservative care, an option for lumbar decompression while avoiding traditional surgery. Early results in my practice have been very encouraging and I look forward to participating in a broader research study to develop more evidence.”

“This comes at an exciting time for VertiFlex, as all 24-month follow up in our Superion Interspinous Spacer IDE (investigational device exemption) trial has just completed, and we are preparing to submit our PMA shortly,” Fender added.

The Superion Interspinous Spacer System is developed as a less-invasive spinal implant option for performing indirect decompression, according to the company. Enrollment in a pivotal IDE trial of 470 patients was completed in December 2011, with two-year follow up now complete. The Superion implant is motion preserving and delivered through the same interspinous access platform as Totalis. Superion has been CE marked in the European Union since 2007 and currently is an investigational device in the United States.

VertiFlex was founded in 2005 and is focused on developing minimally invasive technologies for performing indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery, providing options for interventional spine physicians and less-invasive options for traditional spine surgeons.