ConforMIS, Inc. 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.
The iDuo surgical procedure utilizes patient-specific instrumentation called iJigs that are designed from the same imaging data as the implant. The iJig cutting and placement guides eliminate manual sizing during surgery and provide tactile guidance to precisely place the implant, significantly reducing the number of bone cuts required for the surgery, simplifying the steps, and increasing the reproducibility of surgical results.
The first iDuo surgery in Europe was performed by Professor Joachim Grifka, MD, and Franz Xaver Köeck, MD, at the Department of Orthopedics at the University Hospital of Regensburg in Bad Abbach, Germany on June 18, 2009.
We are very pleased that, thanks to the iDuo, we are now able to offer our patients an alternative to a total knee replacement, said Professor Grifka, Chair of the Department of Orthopedic Medicine at the University of Regensburg.
Due to the fact that the iDuo requires only the damaged parts of the cartilage to be removed, the healthy cartilage and bone tissue can be saved, said Dr. Köeck. Only a very small bone resection is required to perform the surgery.
Since 2007, orthopedic implants such as those developed and manufactured by ConforMIS are considered class three devices for CE Mark certification, meaning the products are subjected to the most rigorous examination before being approved.