Musculoskeletal Clinical Regulatory Advisers said Wednesday it aided VertiFlex in winning pre-market approval from the FDA for its Superion interspinous spacer. The neuro-musculoskeletal and orthopedic advising and research organization said its assistance to Vertiflex helped reduce the average 26-month PMA review period to only 14 months. The Superion approval, won in May, marks the 1st spinal […]
VertiFlex said today that it won pre-market approval from the FDA for its Superion interspinous spacer for treating moderate lumbar spinal stenosis.
A FDA advisory panel has recommended the agency approve VertiFlex Inc.’s Superion interspinous spacer system for the treatment of spinal stenosis.
According to VertiFlex, the panel based their vote largely on results from the company's 470-patient clinical trial.
December 11, 2014 by Mark Hollmer
The FDA postponed a meeting of 1 of its advisory panels that’s slated to review the pre-market approval application for the Superion spine implant made by VertiFlex.
September 17, 2014 by Brad Perriello
VertiFlex Inc. won a date with an FDA advisory panel to review the data behind its Superion interspinous spacer ahead of its bid for pre-market approval from the watchdog agency.
VertiFlex won reimbursement coverage from the Centers for Medicare & Medicaid Services for the company’s Totalis direct decompression system for treatment of spinal stenosis.
San Clemente, Calif.-based VertiFlex said the technology is "not core to the ongoing strategic operations of the company" and that it plans to us the cash for its line of lumbar spinal stenosis products.
San Clemente, Calif.-based Vertiflex announced FDA clearances for its Totalis Direct Decompression System and UniVise Spinous Process Fixation System.
The twin regulatory wins, received in Noveber and December respectively, expand the company’s product portfolio for the treatment of lumbar spinal diseases, the company said.
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