Tuesday, February 26, 2008

iUni Resurfacing Knee Approved in US, Now Goes to Europe

Filed under: Orthopedic Surgery

ConforMIS, Inc., a Burlington, MA company, is betting big on the fairly new bone-sparing resurfacing devices, thought to be especially useful for younger and more active patients with osteoarthritis. The company's individually personalized device called iUni™, a uni-compartmental knee arthroplasty system, already approved by the FDA, has now been OK'ed by European regulators with the CE Mark.

More about the device, taken from the product page at ConforMIS:

How it Works

The personalized iUni is designed to form fit onto the subchondral bone surface of the patient's femoral condyle, replacing the damaged cartilage with a cobalt chrome surface.

Only a small bone cut is performed posteriorly for the femoral component. The bone cut is designed to be external to the posterior bone cut of the other uni-compartmental devices, thereby preserving future treatment options.

The tibial implant is a 7mm thick polyethylene component inserted into a cobalt chrome tray. After proper MCL tensioning using the iJig patient-specific instrumentation, only a small amount of tibial bone is removed.

The advantage of the iUni is that the damaged cartilage is resurfaced, maintaining the integrity of the femoral subchondral bone plate of the affected compartment.

Indications

The ConforMIS iUni is intended for use in one compartment of the osteoarthritic knee, to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone to support the components.

Candidates for unicondylar knee repair include those with joint impairment due to osteoarthritis or traumatic arthritis of the knee; previous tibial condyle or plateau fracture, creating loss of function; and valgus or varus deformity of the knee.

Product page: iUni...

Press release: ConforMIS, Inc. Receives CE Mark Certification for Minimally Invasive Patient- Specific Implants and Instrumentation...

Resurfacing implants flashbacks: Cormet™ Hip Resurfacing System ; Birmingham Hip, or How to Sell Fresh Hips to Boomers; The AIC Hip Buffer™

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