VertiFlex, a medical device manufacturer based in San Clemente, California, received clearance from the United States Food and Drug Administration for its UniVise Spinous Process Fixation System and the Totalis Direct Decompression System.
According to a press release by the company, the regulatory win will help beef up the company’s existing portfolio for lumbar spinal disease treatment systems. The UniVise Spinous Process Fixation system and the Totalis Decompression System can assist surgeons in lumbar spine decompressions through a minimally-invasive operation.
Earl Fender is the CEO and president of VertiFlex. In prepared remarks, he said, "These regulatory clearances represent important milestones for VertiFlex as we rapidly expand our portfolio of innovative interspinous technologies." He continued, "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."
In recent years, VertiFlex has also sold off some of its technologies. In 2010, the company sold some of its spinal reconstruction product lines to Exactech Inc.