WASHINGTON, June 24, 2015 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve VertiFlex Inc.’s Superion® Interspinous Spacer for use in the treatment of moderate spinal stenosis. This is the eighth successful PMA in which MCRA has assisted a client since 2006.
MCRA was retained in May 2013, at the early stages of PMA strategy, to assist with PMA development and to lead all interactions and correspondence between the FDA and VertiFlex. The FDA announced the PMA approval decision on May 20, 2015 resulting in a 14-month review time between PMA submission and FDA approval. MCRA and VertiFlex reached this success in nearly half of the average 26-month review period experienced in the past decade for other PMA sponsors in the orthopedic and spine fields. Additionally, the Superion® marks the first spinal device to go to an FDA panel meeting and receive a PMA approval decision since 2007, with the last 4 failing to receive a favorable FDA decision.
“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,” said Earl R. Fender, President and Chief Executive Officer of VertiFlex, Inc.
David Lown, General Manager, added “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.”