Geistlich Pharma Granted FDA Breakthrough Device Designation for Chondro-Gide® Articular Cartilage Cover
WOLHUSEN, Switzerland--(BUSINESS WIRE)--Geistlich Pharma, a Swiss developer of biomaterials for regenerative therapies in orthopedics, announced that the Chondro-Gide® articular cartilage cover has been granted a Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration. Chondro-Gide® is a collagen membrane that is used in a single-step cartilage repair technique.
The Breakthrough Devices Program was designed to expedite the path from development to review for medical devices that offer new, more effective diagnosis or treatment options to patients with life-threatening or irreversibly debilitating diseases or conditions. The program ensures timely access to devices that are likely to promote public health.
Chondro-Gide® is a highly purified collagen membrane that leverages the body’s own healing potential. It is used in combination with bone marrow stimulation (BMS) to treat cartilage defects.
More than 10 years of clinical success in Europe have shown the product to be a cost-effective single surgery treatment for repairing cartilage lesions, enhancing the effect of established bone marrow stimulation techniques. Repair of cartilage defects and injuries is key in alleviating or preventing pain and slowing the progression of damage which can lead to osteoarthritis.
“The device is versatile and can be used in minimally invasive procedures where indicated,” says Carrie Hartill, Business Unit Director for Geistlich Surgery. “Cost effective, single surgery cartilage repair devices are not currently available in the USA, and Chondro-Gide® will fill this unmet clinical need.”
The company looks forward to working with FDA to provide clinical data for the clearance of this product and making it available to patients in the USA.
About Geistlich Pharma
Geistlich Pharma has existed since 1851 and is family-owned. It specializes in the regeneration of bone, cartilage and tissue. More than 700 employees worldwide work for Geistlich in the area of regenerative medicine. With its twelve affiliates and 60 distribution partners, Geistlich’s medical devices and medicinal products reach around 90 markets worldwide.
Carrie Hartill, Director, Geistlich Surgery