California orthopedic device developer Moximed said today it enrolled the 1st patient in an FDA approved investigational device exemption trial of its next-gen Atlas unicompartmental unloading knee implant.
The Atlas is designed to treat osteoarthritis knee joint pain in patients ages 35 to 65 whose condition has not degenerated enough to require arthroplasty. The device is a joint unloader placed along the knee to absorb excess load and buy time.
The cylindrical shock absorber component is about as long as a standard house key and has the diameter of a pencil, and the bases that attach to the bone have a footprint a bit larger than a quarter. Once the osteoarthritis becomes too severe, Atlas can be taken out to make room for a full knee replacement as needed.
“The Atlas System provides the same 30 lbs of joint unloading with a significantly smaller implant and anatomically-guided surgical technique. Patients intuitively understand the concept of a shock absorber and are excited about a procedure that preserves their own anatomy without the bone cuts associated with joint replacement. I am looking forward to enrolling my first patients in the Atlas study,” principal US investigator Dr. Jack Farr of Indiana’s OrthoIndy Cartilage Restoration Center said in a prepared release.
“I’m pleased to treat the 1st patient in the Atlas IDE study. I see in my practice a tremendous number of younger, early OA patients who are seeking an alternative to arthroplasty that will allow them to maintain a highly active lifestyle. Load distribution plays an important role in early osteoarthritis, and these patients could potentially benefit from a joint unloading procedure,” Dr. Andreas Gomoll of Harvard Medical School said in prepared remarks.
“Beginning a US study with the Atlas System is a noteworthy accomplishment for the company. Following on the maturing data from the pivotal study of our previous generation device, we are now excited to study the Atlas System for US patients in the clinical setting. We anticipate the Atlas IDE study will reproduce the positive outcomes and safety data presented from the first international studies of the device,” CEO Kevin Sidow said in a prepared statement.
The company won CE Mark approval in the European Union in December last year.