VertiFlex has announced it has received FDA 510(k) clearance for the Totalis direct decompression system and the UniVis spinous process fixation system.
“These regulatory clearances represent important milestones for VertiFlex as we rapidly expand our portfolio of innovative interspinous technologies,” said Earl R Fender, president and chief executive officer of VertiFlex, “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.”
According to a press release, 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 uses VertiFlex’s 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 press release stated that 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 press release added that 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 iInterspinous spacer system (ISS) is a motion-preserving spinal implant system for the treatment of moderate lumbar spinal stenosis.