Ensemble Orthopedics, Inc. announced today the first implantation of the FDA-cleared Ensemble CMC™, the first implant in a product line of minimally invasive joint replacements for the hand and wrist. The surgery was performed by Henry T. Leis, M.D. on March 23, 2021 at Memorial Hospital–Gulf South Surgery Center in Gulfport, Mississippi.
The Ensemble CMC™ was designed to expand the treatment options for osteoarthritis of the carpometacarpal (CMC) joint to treat a broader range of patients using a minimally invasive, simple surgical procedure that offers the potential for shorter recovery times. Its proprietary saddle shape replaces the damaged bearing surfaces of the metacarpal and trapezium bones with an interpositional implant allowing for normal, pain-free motion. The implant is constructed using On-X® pyrocarbon – a high-strength, low-friction, biocompatible material which has shown superior wear resistance against bone when compared to metals or ceramic.
“We are proud to be the first center to implant the Ensemble CMC™,” said Dr. Leis of Bienville Orthopaedic Specialists. “This technology provides a promising alternative to the more invasive procedures that are available to treat osteoarthritis of the CMC. We are excited to be able to offer our patients this new solution.”
“Osteoarthritis of the hand is a debilitating disease that affects 40% of U.S. adults by age 85,” said William Ogilvie, President and CEO of Ensemble Orthopedics. “Our innovative treatment approach inserts an implant through a small incision while retaining the surrounding soft tissues that stabilize the joint. Ensemble is dedicated to bringing this stemless, interpositional philosophy to the other joints of the hand and wrist.”
“The collaboration between our team and Dr. Leis to achieve the first implantation of the Ensemble CMC™ was enjoyable and productive,” Ogilvie added. “We will continue to train select surgeons on the Ensemble procedure, enabling us to complete our controlled commercial launch.”Ensemble Orthopedics, a medical device company based in Austin TX, develops proprietary, interpositional implants designed to employ minimally invasive surgical techniques, thereby retaining stabilizing tendons and ligaments, for the treatment of arthritis in the hand and wrist.