ConforMIS Inc. won CE Mark approval in the European Union for the next generation of one of its custom knee implants, the iUni G2.
Jong Lee, senior vice president for business strategy at the Burlington, Mass.-based firm, told MassDevice that the system is designed to replace either the medial or lateral compartment of the knee. The device, which won 510(k) approval from the Food & Drug Administration in September 2009, is custom-designed for each patient and includes instruments designed to conform with their physiology. Lee said ConforMIS introduced a new element of the system it’s calling iView, which is an image of the patient’s knee provided to the surgeon before the operation detailing the exact positioning of the device and the anatomy of the patient’s knee.
ConforMIS also makes the iDuo implant, designed to replace either the lateral or medial compartment and the patella-femoral joint, or kneecap, and is developing a total knee replacement called the iTotal. Last year, founder and CEO Philipp Lang told MassDevice that the company expected to launch the device some time this year, using some of the $50 million it raised in a July 2009 Series D funding round.
Today Lee said the company hopes to see the iTotal hit the market during the second half of the year.
"For us as a company, it’s one of the most important product introductions that we have," he said.
ConforMIS is rolling out the iUni G2 in Europe "as we speak," Lee added.