Ceterix Orthopaedics said today it won FDA 510(k) clearance for its NovoStitch Plus meniscal repair system designed for patients with meniscal tearing.
The device is a next-generation version of the company’s NovoStitch, designed to treat a variety of different meniscal tears, the Menlo Park, Calif.-based company said.
“The main difference is the NovoStitch Plus has a cartridge-based system and the cartridge has an integrated suture in it, preloaded,” CEO John McCutcheon told MassDevice.com in an interview. “It’s a real improvement in ease of use and number of steps necessary to complete the procedure.”
The newly approved NovoStitch Plus is able to pass its pre-loaded sutures around tears to supply complete coverage of the tear during the repair procedure, McCutcheon said. That’s something other devices on the market can’t do, he added.
“Ours is the only one that has what we call a circumvential compression stitch – the ability to pass a stitch from the tibial side of the miniscus to the superior side, the femoral side, and completely surround the tear,” McCutcheon said.
McCutcheon said the rest of the meniscal tear repair systems only cover “vertical” tears, which make up 10-15% of meniscal injuries.
“Other devices can only approach tears that are perpindicular to it, so they have a very limited number of tears they can treat,” McCutcheon said.
The 1st procedure with the device was performed last week, McCutcheon said, and the company plans to continue its rollout across the U.S. within the next few months, though it has no immediate plans to seek certification in other markets.
“We’re focused entirely on the US market at this point. We will be looking to international markets probably at the end of 2016,” McCutcheon said.
“The NovoStitch Plus meniscal repair system represents a significant improvement to one of the most innovative technologies developed for knee procedures in many years. The NovoStitch device has allowed me to preserve the meniscus for many of my patients, significantly reducing their likelihood of arthritis or a total knee replacement later in life. I am looking forward to incorporating the new device into my practice,” Dr. James Lee Pace of the Children’s Hospital Los Angeles said in prepared remarks.