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 device to go to an FDA panel meeting and receive a PMA approval since 2007 with the last 4 failing to receive a favorable FDA decision, MCRA said.
“In the changing spinal landscape of minimally invasive surgical options, the level-one evidence of the Superion is an achievement for everyone at VertiFlex. We are very happy with our decision to entrust the MCRA team with assisting us in this important phase of our company. We could not be more impressed with MCRA’s ability to understand our technology and the volumes of supporting clinical data while working hand-in-hand with VertiFlex to achieve this important regulatory milestone,” Vertiflex CEO Earl Fender said in prepared remarks.
“MCRA’s integrated team of regulatory, clinical, reimbursement, and quality assurance leaders allows for us to assist clients in a holistic manner that today’s complexities require for achieving success. We are extremely pleased to have had the opportunity to advise and counsel VertiFlex through the FDA’s rigorous PMA process enabling them to provide U.S. patients with a proven, advanced technology,” MCRA general manager David Lown said in a press release.
The approval followed an FDA advisory panel recommendation in February that the device be approved, based on data from a 470-patient trial that showed a greater than 80% clinical success rate at 24 months.
VertiFlex won CE Mark approval for the Superion in the European Union in 2007.
