Here are five things to know:
1. VertiFlex retained MCRA in May 2013 in the early stages of achieving PMA to assist with PMA development and lead correspondence with the FDA. The FDA cleared Superion for a 13-month PMA on May 20, 2015.
2. The typical review period for PMA approval is 26 months in the orthopedic and spine fields, and VertiFlex was able to achieve approval in just 14 months with MCRA’s help.
3. Superion is the first spinal device to go to an FDA panel meeting and receive a PMA approval since 2007. The last four attempts failed to receive a favorable FDA decision.
4. This is the eighth successful PMA MCRA has helped with since 2006. MCRA’s integrated team includes regulatory, clinical, reimbursement and quality assurance leaders.
5. In an investigational device exemption study, Superion demonstrated durability beyond the 24-month primary endpoint and continued to perform well through 36 months. The study included 470 patients and was a multicenter, prospective and randomized controlled trial.
“In the changing landscape of minimally invasive surgical options, the level-one evidence of the Superion is an achievement for everyone at VertiFlex,” said President and CEO Earl R. Fender.
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