Ceterix Orthopaedics Wins FDA Approval for Next-Gen Meniscus Repair Device

Ceterix Announces FDA Clearance and U.S. Commercial Availability of Next-Generation Meniscus Repair Device

NovoStitch Plus Enables Meniscus Preservation for More Patients

MENLO PARK, Calif.--(BUSINESS WIRE)--

Ceterix^® Orthopaedics, Inc., a developer of novel surgical tools that improve a surgeon’s ability to perform minimally invasive orthopaedic procedures, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and U.S. commercial availability of the company’s 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, meniscectomy significantly increases the risk of arthritis or total knee replacement later in life.¹ 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.²

The NovoStitch Plus device allows orthopaedic 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 orthopaedic surgeons to treat complex injuries. The next-generation NovoStitch Plus device incorporates a pre-loaded suture implant, a design innovation that improves 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, 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. Findings of the study were presented at the 20th annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).²

About Ceterix Orthopaedics

Ceterix Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue injuries such as meniscus tears, hip and shoulder labrum tears, and rotator cuff tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel suture passing device enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch suture passer is indicated for passing suture through soft tissue in orthopaedic surgery (the specific indication of meniscal tears repair has not been cleared by the FDA). The company is based in Menlo Park, Calif. and is backed by investors Novo Ventures, Versant Ventures and 5AM Ventures. For more information, please visit www.ceterix.com.

¹ Papalia, R. et. al. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin. 2011; 99:89 – 106.

² Feeley, B. et. al. The Cost-Effectiveness of Meniscal Repair versus Partial Meniscectomy: A Model-based Projection of Clinical Outcomes and Costs in the United States Healthcare System. ISPOR Annual Meeting 2015.

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• Health Care Industry
• total knee replacement
• Food and Drug Administration
• Orthopaedics