Vertiflex®, Inc. Announces Decision by the Centers for Medicare & Medicaid Services
January 14, 2014
SAN CLEMENTE, CA (January 14, 2014) – Vertiflex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies, announces The Centers for Medicare & Medicaid Services (CMS) has released its final Decision Memorandum on coverage 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 Chief Executive Officer of Vertiflex, Inc. “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.”
“This comes at an exciting time for Vertiflex, as all 24 month follow up in our Superion® Interspinous Spacer IDE Trial has just completed, and we are preparing to submit our PMA shortly,” said Fender.
“The Totalis procedure has been a great addition to my practice,” commented Dr. Timothy Davis, Medical Director of Orthopedic Pain Specialists in Santa Monica, CA. “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.”
The Totalis Direct Decompression System is a unique set of surgical instruments designed to perform minimally invasive decompression of the lumbar spine. Totalis utilizes 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 anesthesia. The Totalis System was 510(k) cleared by the FDA in November, 2012, and has successfully completed Alpha launch in the U.S.
The Superion Interspinous Spacer System (ISS) is the least invasive spinal implant option for performing indirect decompression. Enrollment in a pivotal IDE trial of 470 patients was completed in December, 2011 with 2-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 since 2007 and is currently an investigational device in the U.S.
About Vertiflex, Inc.
Vertiflex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, Vertiflex has developed proprietary, minimally invasive technologies for performing both 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 new options for interventional spine physicians and less invasive options for traditional spine surgeons. To date, Vertiflex has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis.