Moximed®, Inc. tells us its next-generation knee joint unloader for pre-arthroplasty patients, tagged Atlas, has gained CE Mark and seen first commercial use. The Atlas Knee System, its . Coinciding with the CE Mark, the first commercial uses of the product occurred in Europe.
Background
First performed in the 1960’s, knee joint replacement for osteoarthritis has provided benefit for many patients, but younger or active patients experience higher reoperation rates and higher levels of residual pain and dissatisfaction, bringing the procedure into question for certain cohorts.
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, articularly targeting this younger generation of OA sufferers.
Moximed’s clever Atlas System is specifically designed for patients wishing to preserve both their knee and their lifestyle. 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.
The procedure is both joint-preserving and reversible, meaning that patients have future treatment options available to them should their osteoarthritis become more severe.
Physician comments
Dr. Claudio Zorzi MD, of Ospedale Sacro Cuore Don Calabria in Negrar (Verona), Italy, and his associate, Vincenzo Madonna, MD, have the largest worldwide experience with Moximed’s earlier generation joint unloader and performed the first implant since CE marking of the new Atlas system. Dr Zorzi stated: “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.”
Following its evaluation in a 40 patient, prospective, multi-center clinical study, one investigator, Konrad Slynarski, MD, of Lekmed Szpital in Warsaw, Poland commented, “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.”
Another of the investigators in the study was Willem van der Merwe, MD, FCS (SA) of the Sports Science Orthopaedic Clinic in Cape Town, South Africa, who noted, “I enrolled my full allotment into the study and could have enrolled additional subjects. I believe the Atlas System could be a pre-arthroplasty treatment solution for people who are too young or not ready for joint replacement, and I look forward to adding the service as a regular part of my practice.”
Company comments
“We are pleased with the early clinical results and surgeon interest in the Atlas System,” stated 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.”
Source: Moximed, Inc.
published: December 15, 2015 in: Approval/Clearance, Clinical Studies/Trials, Knee, News