Meniscus Repair Instrument Gets Rapid FDA Clearance
It took the FDA about 30 days to clear Ceterix Orthopaedics' next-generation meniscal repair instrument. With roughly one million meniscus repairs performed annually, this is one of the most common arthroscopic procedures in the U.S.
Meniscal tears are most often treated via a meniscectomy, where a surgeon removes the torn tissue. Ceterix says their newly cleared device is designed to allow surgeons to place stitches arthroscopically in tight joint compartments, to treat meniscal tears that had previously been unrepairable.
Peter Kurzweil M.D., president of Memorial Orthopaedic Surgical Group, said that Ceterix’s NovoStitch Pro Meniscal Repair System "represents a significant improvement to one of the most innovative technologies developed for arthroscopic knee repair. The technological enhancements incorporated into the new system offer the potential to repair tear types that were previously considered difficult or impossible to sew, with improved control and access for the surgeon.”
In a prepared statement responding to the FDA clearance of its innovative device, CEO of Ceterix John McCutcheon said “This FDA clearance is another important milestone in our mission to reduce the number of meniscectomies and to save the meniscus. Ceterix continues to be the leader in meniscal repair by providing innovations that preserve tissue and sustain the natural biomechanics of the knee joint.”
The company referenced a 2015 health economics study which determined that effective meniscal repair can result in long-term cost savings versus meniscectomy due to the reduced risk of requiring costly future interventions. Meniscectomy has been shown to increase a patient’s risk of developing osteoarthritis, which may lead to total knee replacement later in life.
To get a better understanding of how this device works, check out the video below: