Enhances Focus on Revision Arthroplasty with Pilot Launch of Three New Revision Systems in Fourth Quarter
GAINESVILLE, Fla. (Sept. 30, 2015) – Exactech, Inc. (Nasdaq: EXAC), a worldwide developer and producer of bone and joint restoration products, announced today the successful first surgeries performed with its new revision knee system. Designed to provide a reproducible surgical technique for treating complex revision total knee replacement patients, the system includes a comprehensive implant offering and ergonomically designed instrumentation. Pilot launch is scheduled through the remainder of the year with full market availability in the United States in 2016.
Orthopaedic surgeons Bernard Stulberg, MD, of St. Vincent Charity Medical Center in Cleveland, Ohio, and Geoffrey Westrich, MD, of Hospital for Special Surgery in New York, NY performed the first cases using the knee system during the past week.
“I was honored and pleased to be the first to use the new instruments and devices for revision of a failed knee replacement,” Dr. Stulberg said. “The implant provided excellent early stability and kinematics, and allowed my patient to be discharged to home within two days. The instruments were intuitive, comfortable to use and allowed for a straightforward and accurate approach to assessing bone loss, and for re-establishing proper implant position, alignment and stability. This was a satisfying experience that I believe many surgeons will be able to share, as this innovative new implant and instrument system helps them to address the myriad of problems encountered in revision total knee replacement.”
The revision knee system addresses Exactech’s knee design philosophy of delivering performance over time in a streamlined procedure. The evolutionary design incorporates clinically recognized, patented designs and proprietary net compression molded polyethylene. Combined with modern, user friendly instrumentation, the revision knee system is designed for operating room efficiency and reproducible outcomes, case after case.
“In developing Exactech’s new revision knee system, the team focused on reproducibility and efficiency while also leveraging proven design elements that have delivered excellent long-term clinical outcomes,” Dr. Westrich said. “The first case was a great success.”
According to Exactech CEO David Petty, the knee system is one of three new revision implant and instrumentation systems that are making their clinical debut. The company is also piloting its new revision hip stem and a shoulder humeral reconstruction prosthesis. “We are reaffirming our commitment to revision arthroplasy,” Petty said. “It is our goal to deliver patient-driven solutions that allow surgeons to provide a wide continuum of care. Clinical use of this knee system is the culmination of years of collaboration with world-renowned revision total knee surgery experts.”
Exactech worked closely with a design team of experienced revision knee surgeons to develop this revision system: Bernard Stulberg, MD, St. Vincent Charity Medical Center; Geoffrey Westrich, MD, Hospital for Special Surgery; Daniel C. Allison, MD, Cedars-Sinai Medical Center; James Huddleston, MD, Stanford Medicine; Richard Parkinson, MB ChB, FRCS, Spire Murrayfield Hospital Wirral, United Kingdom.
The new Exactech revision knee system is indicated for use in skeletally mature patients undergoing surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; this device is also indicated for revision of failed previous reconstruction where sufficient bone stock and soft tissue integrity are present.