The FDA has cleared the NovoStitch® Plus, a device that assists doctors in preserving the meniscus, allowing it to heal.
Founded in 2010, Ceterix® Orthopaedics, Inc, is a company that develops surgical tools to help physicians to treat soft tissue injuries, such as meniscus tears. The company has recently announced that the FDA has cleared the NovoStitch® Plus meniscal repair system.
Patients who have a tear in the meniscus (the thin cartilage between the joint of the knee), are often treated by removal of the meniscus, which can eventually lead to arthritis of the knee, or increase the need for total knee replacement. Alternatively, repairing the meniscus, by applying a suture, can improve long-term patient outcomes, and is relatively less expensive than total removal of the meniscus.
This is where the NovoStitch® Plus comes in, aiding the surgeon to navigate the suturing procedure, by enabling the positioning of a compression stitch around the meniscus. The NovoStitch® Plus is designed to hold a pre-loaded suture, and reduces the steps involved in the surgical procedure.
The NovoStitch® Plus device has been evaluated in biomechanical studies that have shown NovoStitch®-delivered sutures to be on par, or better than the current gold-standard surgical approach for meniscus tears.
Ceterix News Release “Ceterix Announces FDA Clearance and U.S. Commercial Availability of Next-Generation Meniscus Repair Device” Available from: http://www.ceterix.com/ceterix-announces-fda-clearance-and-u-s-commercial-availability-of-next-generation-meniscus-repair-device/ Last Accessed: September 25, 2015.
Written by Deborah Tallarigo, PhD