Chondro-Gide® Articular Cartilage Cover: FDA approval as a Breakthrough Device
The Breakthrough Devices Program was developed in order to expedite the pathway from development through to testing of highly promising medical devices. It focuses on novel, more effective diagnostic and treatment methods for patients with life-threatening or incurable diseases and debilitating conditions. The program guarantees timely access to products which are highly likely to promote public health.
Ten years of clinical success in Europe
Chondro-Gide® is a highly purified collagen membrane that exploits the body’s own healing potential. It is used in combination with bone marrow stimulation (BMS) to treat cartilage defects. More than ten years of clinical success in Europe have shown that the product is a cost-effective, one-step treatment for repairing cartilage lesions and that it enhances the effectiveness of established bone marrow simulation techniques. Repairing cartilage defects and injuries is the key to relieving or avoiding pain. It slows down the progression of damage that can result in osteoarthritis.
Versatile product for minimally invasive surgery
“The product is versatile and can be used for minimally invasive surgery where this is indicated“, states Carrie Hartill, Business Unit Director for Geistlich Surgery. Reasonably priced products for one-step cartilage repair are not currently available in the USA. Chondro-Gide® meets this clinical need. Geistlich Pharma appreciates being able to collaborate with the FDA in providing the clinical data required for clearance of the product so that it can be made available to patients in the USA.