Graftys’ Bone Cements Earn Expanded CE Mark Indications

Aix-En-Provence, France-based Graftys SA, which makes orthopedic biomaterials, has earned expanded CE mark designation for the use of two if its bone cements for the treatment of bone marrow lesions caused by traumatic injury.

The cements are Graftys HBS and Graftys Quickset, both of which are touted to be highly highly injectable and resorbable. They are both calcium phosphate cements. HBS is designed for minimally invasive approaches, while Quickset has a quicker setting time, is very cohesive, and features an improved mechanical resistance in compression.

Subchondral bone marrow lesions, also known as bone marrow edema, results in loss of bone volume and micro fractures and loss of mechanical strength of the subchondral bone above or below the knee joint, which may cause an inflammatory reaction and damage the articular cartilage.

“When these bone marrow lesions occur in the subchondral condyle or under the tibial plateau, they can create pain and lead to total knee replacement once traditional treatments fail” said Jean-Marc Ferrier, vice president of clinical and regulatory affairs for Graftys. “This new surgical treatment, which involves minimally invasive injection of calcium phosphate cement, under radiographic guidance, can provide orthopedic surgeons with a new and less invasive method of treatment for patients who suffer from this type of subchondral pain.

“We are very pleased to have obtained approval for this indication in Europe,” said General Manager Aurélien Valet. “This strengthens Graftys’ market position, which now includes four CE approvals in Europe and three [U.S. Food and Drug Administration] 510(k) clearances. Graftys will set up a clinical data registry aiming at demonstrating the efficacy of our products in the treatment of post-traumatic bone marrow lesions.”