San Clemente-based VertiFlex Inc., an innovator in medical devices focused on the advancement of minimally invasive technology for the treatment of lumbar spinal stenosis, has received FDA 510(k) clearance for two new products: the Totalis Direct Decompression System and the UniVise Spinous Process Fixation System.
“These regulatory clearances represent important milestones for VertiFlex as we rapidly expand our portfolio of innovative interspinous technologies,” said Earl Fender, the 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.”
The Totalis Direct Decompression System is composed of a set of surgical instruments that utilize VertiFlex’s interspinous access platform, which is comprised of both reusable and disposable tools that are used to remove targeted bone and soft tissue, to perform minimally invasive direct decompressions of the lumbar spine.
As a representation of the company’s core technology and intellectual property, the UniVise Spinous Process Fixation System is the least invasive spinous process fixation system available on the market to date, according to company representatives. It is a spinal implant system that fixates the spinous processes as an adjunct to lumbar spinal function, and was cleared last month. Both of these systems emerged after seeing the benefits from VertiFlex’s established Interspinous Spacer System, a motion-preserving spinal implant system that is used to treat moderate lumbar spinal stenosis.
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