VertiFlex has announced it has received FDA clearance of two new products: the Totalis direct decompression system and UniVise spinous process fixation system, according to a news release (pdf).
The Totalis system is a set of surgical instruments designed for performing minimally invasive direct decompressions of the lumbar spine. It was cleared by FDA in November 2012.
The UniVise system is a spinal implant system designed to provide fixation of the spinous processes as an adjunct to lumbar spinal fusion. It was cleared by FDA in December 2012.
"These regulatory clearances represent important milestones for VertiFlex as we rapidly expand our portfolio of innovative interspinous technologies," said Earl R. Fender, president and CEO of VertiFlex, in the 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."
VertiFlex, a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, is headquartered in San Clemente, Calif.
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