It took the FDA about 30 days to clear Ceterix Orthopaedics, Inc.’s next-generation meniscal repair system. Meniscus surgery is one the most common arthroscopic procedures in the U.S., with roughly one million performed annually.
Quick FDA Clearance for Meniscus Repair Instrument
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Meniscal tears are most often treated via a meniscectomy where a surgeon removes the torn tissue.
NovoStitch Pro Meniscal Repair System
Ceterix’s NovoStitch Pro Meniscal Repair System, “represents a significant improvement to one of the most innovative technologies developed for arthroscopic knee repair,” said Peter Kurzweil, M.D., president of Memorial Orthopaedic Surgical Group in Long Beach, California. “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. I look forward to incorporating it into my practice.”
The repair system, according to FDA 510(k) clearance documents, is a handheld, disposable surgical instrument coupled with an implantable suture for the approximation of soft tissue in meniscal repair procedures. The system is comprised of a delivery handle and a suture cartridge, both of which are provided sterile.
In an April 16, 2018 announcement, the company said the NovoStitch enables surgeons “to place stitches arthroscopically in tight joint compartments, allowing them to address complex meniscal tears that have not been amenable to repair in the past. Enhancements in the newly FDA-cleared NovoStitch Pro system include an ergonomic and intuitive handle design, the addition of well-defined visual cues for precise stitch placement, and improved control and stability from upper jaw texturing.”
The company referenced a 2015 health economics study which determined that effective meniscal repair can result in long-term cost savings vs. 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.
Predicate Device
The repair system, according to FDA documents, is a next generation of the predicate device, the NovoStitch Plus Meniscal Repair System. The new system passes size 2-0 braided, nonabsorbable, polyethylene surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with polyethylene suture are attached.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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