|NovoStitch suture passer--Courtesy of Ceterix|
Silicon Valley's Ceterix received the FDA's 510(k) clearance earlier this week for its second-generation meniscal repair device, which prevents the need for removal of the piece of cartilage in the knee, thereby sparing patients from arthritis or total knee replacement later in life.
The NovoStitch Plus suture passer has two arthroscopically inserted jaws that are positioned on the top and bottom of the meniscus via a small "keyhole," or entry port, in the front of the knee. Next, the needle and suture are advanced through the meniscus from the bottom to the top jaw of the device. Once the sutures are in place around the injured part of the meniscus, the device is removed and knots are manually tied to keep the sutures in place.
"The device passes a suture vertically through the meniscus in a very, very tight space," said Ceterix CEO Dr. John McCutcheon in an interview. The suture passer can treat horizontal tears, while other meniscus repair devices can treat vertical tears, he said, explaining that meniscus repair devices have to be perpendicular to the orientation of the tear that they intend to treat.
Ceterix says the upgraded version of the device contains a preloaded suture implant, which makes the device easier to use and cuts the number of steps in the meniscus repair procedure.
"Before, the surgeon had to load the suture themselves," McCutcheon said, adding that the previous iteration of the device had to be inserted in the knee twice, while the new version is inserted once.
Currently most surgeries of the meniscus involve total or partial removal the body part (meniscectomy). McCutcheon hopes to expand the market for meniscus repair, which he said is better than removal over the long run. "The younger you are when you have the meniscus removal procedure, the greater the odds are that you'll get arthritis and need a knee replacement later," he said.
A limited launch of the upgraded NovoStitch Plus is planned for 2015, and a full scale rollout is planned for next year, McCutcheon said. He's aiming to make Ceterix the market leader in meniscus repair.
The company has the venture capital backing of 5AM Ventures, Novo A/S and Versant Ventures. It obtained $35 million in May through a term loan agreement with healthcare investment firm CRG and some of its affiliates.
- read the release