MCRA Assists VertiFlex, Inc. with Obtaining FDA PMA Approval for the Superion® Interspinous Spacer System
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."
About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA's value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA's integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves nearly 450 clients globally.
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery, providing new options for interventional spine physicians and less invasive options for traditional spine surgeons. To date, VertiFlex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis.
For additional information, please visit: www.mcra.com | www.mcraCRO.com.
Contact:
David Lown
General Manager
(202) 552-5800
[email protected]
Logo - http://photos.prnewswire.com/prnh/20150624/225501LOGO
SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC
Share this article