Atlas Knee System From Moximed Receives CE Mark

Moximed Inc. has received CE Mark approval of the Atlas Knee System, its next-generation knee joint unloader for pre-arthroplasty patients. Coinciding with the CE Mark, the first commercial uses of the product occurred in Europe, executives said.

Joint unloading is a proven therapy that has recently become more common as the need for alternatives to end-stage joint replacement becomes more evident. Between 1990 and 2010, the incidence of symptomatic knee OA skyrocketed, particularly among patients 35 – 65 years of age. First performed in the 1960s, knee joint replacement has provided benefit for many patients, but its suitability for active adults of the 21st century is coming under increasing clinical scrutiny. Recent studies show that younger or active patients experience higher reoperation rates and higher levels of residual pain and dissatisfaction. The Atlas System is specifically designed for patients wishing to preserve both their knee and their lifestyle.

“We are proud to have implanted the first CE Marked Atlas Systems worldwide,” said Claudio Zorzi, M.D., of Ospedale Sacro Cuore Don Calabria in Negrar (Verona), Italy. “The Atlas System provides the same amount of joint unloading as the previous generation device, but it now offers a smaller device footprint and a surgical technique customized to the patient’s own anatomy. We anticipate the Atlas System will be used for a significant portion of our knee practice.” Zorzi and his associate, Vincenzo Madonna, M.D., have the largest worldwide experience with Moximed’s earlier generation joint unloader, company officials claim.

The Atlas System design was evaluated in a 40 patient, prospective, multi-center clinical study. One of the study investigators, Konrad Slynarski, M.D., of Lekmed Szpital in Warsaw, Poland said, “My practice treats many young, active patients with mild osteoarthritis. I was amazed at the overwhelming patient interest in receiving joint unloading therapy, and I was very happy with my patients’ consistently rapid recovery and return to daily activities. I have already shifted my practice patterns to offer the Atlas System to patients.”

The Atlas System is an implantable joint unloader for patients with medial knee osteoarthritis. Placed subcutaneously alongside the knee joint, the Atlas System incorporates advanced biomaterials designed to provide a clinically beneficial 13 kg of unloading. Importantly, the Atlas System absorbs excess joint load rather than transfer load to otherwise healthy areas of the joint. The Atlas System features a streamlined surgical technique based on the patient’s own anatomy and allows the surgeon to visually confirm that functional joint unloading is achieved. Finally, the Atlas System is a joint preserving, reversible procedure, meaning that patients have future treatment options available to them should their osteoarthritis become more severe.

The Atlas is CE Marked in Europe and is currently only being made available to select centers. It is not currently approved for sale in the United States.

Another of the investigators in the study was Willem van der Merwe, M.D., F.C.S. (SA) of the Sports Science Orthopaedic Clinic in Cape Town, South Africa, who believes the Atlas System could be a pre-arthroplasty treatment solution for people who are too young or not ready for joint replacement.

“We are pleased with the early clinical results and surgeon interest in the Atlas System,” said Moximed CEO Kevin Sidow. “Building on our seven years of clinical experience with joint unloading, we are confident that the Atlas System will make a positive impact for osteoarthritis patients worldwide. We believe the Atlas System provides a significant segment of osteoarthritis sufferers the joint preserving option that will allow them to live the highly active lives that they expect and deserve.”

Osteoarthritis (OA), the most common form of arthritis, is a degenerative disease affecting the hands, knees, hips, feet and spine. According to the Centers for Disease Control and Prevention (CDC), OA affects 27 million adults in the United States. It is caused by changes in cartilage, the soft tissue that cushions and protects bone, leading to pain and changes in the shape of the joint. In knee OA, as the cartilage wears away, the bone ends may begin to rub against each other, causing severe pain.

Moximed develops osteoarthritis treatment technology. Moximed is supported by world-leading venture investors including New Enterprise Associates (NEA), Vertex Venture Holdings Ltd., Gilde Healthcare Partners, Morgenthaler Ventures, and GBS Venture Partners.