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Ceterix Orthopaedics gets FDA nod for NovoStitch pro meniscal repair system

Published 17 April 2018

Ceterix Orthopaedics has secured approval from the US Food and Drug Administration (FDA) for its NovoStitch pro meniscal repair system.

This next-generation meniscal repair system is a significant product evolution, offering enhanced technical features to improve the ease of use and workflow for the surgeon.

Ceterix’s NovoStitch systems enable 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 meniscus is a crescent of soft cartilage resting between the femur and tibia that cushions the knee and provides stability to the joint. Meniscal tears are one of the most frequently occurring knee injuries and are most often treated by a procedure called a meniscectomy, in which a surgeon removes the torn tissue.

Meniscectomy has been shown to increase a patient’s risk of developing osteoarthritis, which may lead to total knee replacement later in life. A 2015 health economics study determined that effective meniscal repair can result in long-term cost savings vs. meniscectomy due to the reduced risk of requiring costly future interventions1.

Ceterix’s president and CEO john McCutcheon said: “This FDA clearance is another important milestone in our mission to reduce the number of meniscectomies and to save the meniscus.

“Ceterix continues to be the leader in meniscal repair by providing innovations that preserve tissue and sustain the natural biomechanics of the knee joint.”

Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats a damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope.

Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually.