Results from a multi-center study of Orteq Sports Medicine’s Actifit® meniscal scaffold revealed a greater than 87% survival rate at five-year follow-up, with increased knee function and reduced pain.
Actifit has been implanted in more than 4,000 patients with irreparable meniscal cartilage damage in 30 countries. The synthetic biodegradable polymer is designed to preserve the knee joint and promote new tissue growth in damaged areas of an irreparable meniscus, and offers an alternative to partial meniscectomy.
The scaffold has been granted a Breakthrough Device Designation from FDA, and Orteq expects to present its European clinical data to FDA for analysis within the year. Actifit is also approved under the CE Mark and has obtained regulatory approval in Korea.
Simon Coles, CEO and Director of Orteq Sports Medicine, said, “Our goal in the next two years is to accelerate Actifit regulatory approvals from 30 to 50 countries, expedite our Actifit U.S. filing using the newly-awarded FDA Breakthrough Designation status and rapidly develop the proprietary Actifit polymer platform to other musculoskeletal joints.”
Results from a multi-center study of Orteq Sports Medicine's Actifit® meniscal scaffold revealed a greater than 87% survival rate at five-year follow-up, with increased knee function and reduced pain.
Actifit has been implanted in more than 4,000 patients with irreparable meniscal cartilage damage in 30 countries. The synthetic...
Results from a multi-center study of Orteq Sports Medicine’s Actifit® meniscal scaffold revealed a greater than 87% survival rate at five-year follow-up, with increased knee function and reduced pain.
Actifit has been implanted in more than 4,000 patients with irreparable meniscal cartilage damage in 30 countries. The synthetic biodegradable polymer is designed to preserve the knee joint and promote new tissue growth in damaged areas of an irreparable meniscus, and offers an alternative to partial meniscectomy.
The scaffold has been granted a Breakthrough Device Designation from FDA, and Orteq expects to present its European clinical data to FDA for analysis within the year. Actifit is also approved under the CE Mark and has obtained regulatory approval in Korea.
Simon Coles, CEO and Director of Orteq Sports Medicine, said, “Our goal in the next two years is to accelerate Actifit regulatory approvals from 30 to 50 countries, expedite our Actifit U.S. filing using the newly-awarded FDA Breakthrough Designation status and rapidly develop the proprietary Actifit polymer platform to other musculoskeletal joints.”
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