FDA Clears Ceterix Orthopaedics’ New Meniscal Repair System

Menlo Park, Calif.-based Ceterix Orthopaedics Inc., which makes minimally invasive surgical tools, has earned U.S. Food and Drug Administration (FDA) clearance and the commercial release of its Novostitch Plus meniscal repair system.

Patients with meniscus tears often undergo meniscectomy—total or partial removal of the meniscus—due to the difficulty of access and limitations of current arthroscopic instruments. However, a meniscectomy significantly increases the risk of arthritis or total knee replacement later in life. In contrast, meniscus repair, a procedure in which the tear is sutured and allowed to heal naturally, is associated with improved long-term outcomes and overall cost savings relative to meniscectomy.

The Novostitch Plus device is hoped to allow orthopedic surgeons to more easily address horizontal, radial, and other complex meniscal tears in ways not previously possible. The system enables the placement of a circumferential compression stitch around the meniscus, providing uniform compression during healing and allowing orthopedic surgeons to treat complex injuries. The next-generation Novostitch Plus device incorporates a pre-loaded suture implant, a design innovation meant to improve ease of use and cuts the number of procedure steps by more than half.

“The Novostitch Plus meniscal repair system represents a significant improvement to one of the most innovative technologies developed for knee procedures in many years,” said James Lee Pace, M.D., an orthopedic surgeon and director of the Sports Medicine Program at Children’s Hospital Los Angeles in California after treating the first patient with the next-generation system. “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.”

“We are very pleased to release this important new technology,” said John McCutcheon, president and CEO of Ceterix Orthopaedics. “We believe that the usability improvements in this new device will enable surgeons to provide meniscus repair to an even broader set of patients who need better solutions for this very common knee injury.”

Earlier this year, Ceterix announced the results of several studies related to Novostitch. Positive findings from two biomechanical studies of the Novostitch for meniscus repair were published in Arthroscopy: The Journal of Arthroscopic and Related Surgery. The studies demonstrated that the sutures delivered with Novostitch met or exceeded the strength of those delivered via the gold standard open-surgical approach for two common types of meniscus tears.

Additionally, a health economics study showed that meniscus repair can result in cost savings because of the reduced risk of developing osteoarthritis or needing a total knee replacement.