The Centers for Medicare & Medicaid Services (CMS) has released its final decision memorandum on coverage for percutaneous image guided lumbar decompression for spinal stenosis, which means it allows Medicare coverage of the VertiFlex Totalis direct decompression system for use in patients with lumbar spinal stenosis who are enrolled in an approved coverage with evidence development (CED) clinical study.
“We are very pleased with the decision of CMS to allow CED for this very promising technology,” says Earl R Fender, president and chief executive officer of VertiFlex. “There now exists a pathway for reimbursement for percutaneous image guided lumbar decompression procedures and Totalis for Medicare beneficiaries. We appreciate CMS’ leadership in allowing coverage with evidence development, and look forward to working with them to finalise a robust clinical trial protocol.”
“The Totalis procedure has been a great addition to my practice,” comments Timothy Davis, medical director of Orthopedic Pain Specialists in Santa Monica, USA. “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.”
According to a press release, the Totalis direct decompression system is a unique set of surgical instruments designed to perform minimally invasive decompression of the lumbar spine. Totalis utilises the VertiFlex proprietary 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 anaesthesia. The Totalis system was 510(k) cleared by the FDA in 2012 and has successfully completed Alpha launch in the USA.