|VertiFlex's Superion spinal implant--Courtesy of VertiFlex|
VertiFlex is facing a regulatory setback for its spine implant, as the FDA postponed a meeting slated to review the company's application for premarket approval (PMA) of the device.
The agency's Orthopedic and Rehabilitation Devices panel was originally slated to meet on Dec. 12 but will delay the hearing until Feb. 20, 2015 and will change the meeting's location, the FDA said yesterday in a statement. Regulators did not provide a reason for the change. The news does not bode well for San Clemente, CA-based VertiFlex, as it seeks marketing clearance for its Superion spine implant for treating patients with lumbar spinal stenosis. The company won a date with the FDA advisory panel in September, but for now, its PMA application is on the back burner.
In April, the company submitted final data for its PMA application to the FDA for Superion, touting an IDE trial evaluating the safety and efficacy of the device. The study enrolled 470 patients between June 2008 and December 2012 at 31 centers across the U.S., the largest trial ever completed for spinal stenosis, VertiFlex CEO Earl Fender said in a statement at the time. Superion is implanted through a minimally invasive procedure and is designed to relieve symptoms including leg pain, numbness and cramping in patients with impaired physical function.
VertiFlex has already caught the eye of larger med tech companies, as orthopedic giant Stryker ($SYK) in 2013 bought a number of its spinal surgery implants and technologies for an undisclosed price. Under the terms of the deal, Stryker inherited new products to boost its offerings and VertiFlex walked away with some extra cash in its pocket, funding that helps its beef up R&D for its spinal stenosis device.
But VertiFlex is not the only devicemaker rolling out innovative spinal surgery products. In February 2013, Israeli outfit Premia Spine launched its Total Posterior Solution System for spinal stenosis and slipped disks. In June 2013, California's Vertos Medical raked in $23 million in financing to expand the market for its pain-reducing spinal surgery device. The company's Mild surgery kit helps lumbar spinal stenosis patients stand longer and walk farther without pain, and is applied through a small incision with no implants, sutures, or hospitalization.
- read the FDA announcement
- get the MassDevice story