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FDA clears two new spinal surgery technologies
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VertiFlex Inc. announced FDA 510(k) clearance of the Totalis Direct Decompression System and the UniVise Spinous Process Fixation System, according to a press release.
Cleared in November 2012, the Totalis Direct Decompression System is a set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. Using the company’s interspinous access platform, it reportedly includes both reusable and disposable instruments to treat spinal stenosis by removing targeted bone and soft tissue.
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. Cleared in December 2012, the system leverages the company’s core technology and intellectual property.
“These regulatory clearances represent important milestones for VertiFlex as we rapidly expand our portfolio of innovative interspinous technologies,” Earl R. Fender, president and chief executive officer of VertiFlex, stated in the press release. “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.”