BURLINGTON, Mass.–(BUSINESS WIRE)–ConforMIS, Inc., a privately held orthopedics company that develops and commercializes personalized, minimally invasive medical devices for the treatment of osteoarthritis, today announced it has received CE Mark certification for the iDuo® bicompartmental knee resurfacing implant and accompanying iJig® instrumentation. The iDuo system received CE Mark on June 12, 2009, providing regulatory approval for ConforMIS to begin sales of these products throughout the European Union.
The iDuo is the first and only patient-specific, bicompartmental resurfacing implant on the market. It is designed for patients whose arthritic damage is limited to either the medial or lateral compartment of the knee, in addition to the patellofemoral compartment. Each iDuo is custom designed and manufactured from an individual patient’s CT scan using ConforMIS’ patented iFit® technology, allowing for an entirely personalized fit.
The iDuo resurfaces only the affected areas, preserving far more bone than a traditional knee replacement surgery. The iDuo also preserves the anterior and posterior cruciate ligaments, which helps to maintain natural knee kinematics. The extent of tissue and bone conservation with the iDuo helps patients retain their future surgical options.
“We are pleased to be the first and only company to bring the clinical advantages of our personalized bicompartmental solution to the European market,” said Dr. Philipp Lang, Chief Executive Officer and Chairman of ConforMIS. “Together with our already approved iUni® unicompartmental knee resurfacing system, surgeons now have the ability to treat their patients with resurfacing solutions that are far more bone conserving and minimally invasive than a traditional total knee replacement.”