Approval of Totalis Direct Decompression System and UniVise Spinous Process Fixation System
VertiFlex Inc. officials announces FDA 510(k) clearance of two new products to its portfolio: The Totalis Direct Decompression System and UniVise Spinous Process Fixation System.
“These regulatory clearances represent important milestones for VertiFlex as we rapidly expand our portfolio of innovative interspinous technologies,” states Earl R. Fender, president and CEO of VertiFlex Inc. “We leveraged the unique benefits of our Superion Interspinous Spacer System and strong IP position, to develop these differentiated products to address two significant market opportunities. This accomplishment highlights the company’s core strengths and fundamental commitment to provide physicians with multiple options to best treat patients in the least invasive methods possible.”
The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. The system utilizes VertiFlex’ proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal stenosis by removing targeted bone and soft tissue. The Totalis Direct Decompression System was 510(k) cleared by the FDA in November 2012.
The UniVise Spinous Process Fixation System is a spinal implant system designed to provide fixation of the spinous processes as an adjunct to lumbar spinal fusion. The system leverages the company’s core technology and intellectual property. The UniVise system is the least invasive spinous process fixation system available and was 510(k) cleared by the FDA in December 2012.
The Superion Interspinous Spacer System (ISS) is a motion-preserving spinal implant system for the treatment of moderate lumbar spinal stenosis. Superion is the most advanced and least invasive ISS available or in development for performing indirect decompressions of the lumbar spine. The Superion implant is delivered from a posterior midline approach through a proprietary interspinous access system developed by VertiFlex. The small incision can be closed with a single suture and performed under local anesthesia on an outpatient basis. Once in place, it may reduce pressure on the nerves that cause pain and allow the return to a more active lifestyle. Superion has been CE marked since 2007 and is currently an investigational device in the U.S. Enrollment completed in the Superion pivotal IDE trial with 470 patients in December 2011. It has been implanted in more than 2000 patients worldwide.