The SUN (Safety Using NUsurface) clinical trial is the second one initiated by Active Implants LLC to evaluate its investigational NUsurface meniscus implant.
The device (considered “investigational” in the United States but used clinically in Europe and Israel) is being studied as a treatment option to help patients delay or avoid total knee replacement, according to a media release from Active Implants.
“A damaged meniscus has a very limited healing potential, oftentimes leading to knee replacement surgery,” says Henry Klyce, chief executive officer of Active Implants, in the release. “There is an unmet need in the orthopedic market for a treatment option—such as the investigational NUsurface Meniscus Implant—that can fill the gap between minimally invasive meniscus repair and total knee replacement.”
The NUsurface device, made from medical-grade plastic, mimics the function of the meniscus. It is inserted into the knee joint via a small incision, per the release.
The following orthopedic centers are or will soon be recruiting patients, and additional sites will be added as needed, the release explains:
Phoenix – TOCA, The Orthopedic Clinic Association – Tom Carter, MD; Long Beach, California – Memorial Orthopaedic Surgical Group – Peter Kurzweil, MD; San Francisco – St Mary’s Medical Center – William Montgomery, MD; Boulder, Colorado – Colorado University Sports Medicine – Eric McCarty, MD; Denver – Advanced Orthopedics & Sports Medicine Specialists – Wayne Gersoff, MD.
Additional orthopedic centers include:
Baton Rouge, Louisiana – Baton Rouge Orthopaedic Clinic – Robert Easton, MD; New Orleans – Ochsner Sports Medicine Institute – Deryk Jones, MD; Portland, Oregon – Oregon Sports Medicine – John Greenleaf, MD; Arlington, Texas – Baylor Orthopedic and Spine Hospital – Joseph Berman, MD; Salt Lake City – Salt Lake Regional Medical Center – Andrew Cooper, MD
All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment.
Active Implants’ first study, the VENUS Study (Verification of the Effectiveness of the NUsurface System), has been underway at 10 sites in the United States since January 2015. Both studies are being conducted to obtain FDA approval to sell the NUsurface System in the United States, per the release.
For more information, visit Active Implants.
[Source(s): Active Implants, Business Wire]