VERTIFLEX®, INC. ANNOUNCES DECISION BY THE CENTERS FOR MEDICARE &
PERCUTANEOUS IMAGE GUIDED LUMBAR DECOMPRESSION (PILD) IS ELIGIBLE FOR
COVERAGE WITH EVIDENCE DEVELOPMENT
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 a proprietary, minimally invasive interspinous access platform for performing both indirect and direct decompressions of the lumbar spine. These technologies fill the MIS procedural gap in the stenosis treatment continuum between conservative care and traditional spine surgery. This provides new options for interventional spine physicians and less invasive options for traditional spine surgeons to treat patients who would otherwise undergo more invasive surgery. To date, VertiFlex® has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis.