Exactech: First Implantations of New System (written by Elizabeth Hofheinz @ OTW)
Melting electrons and breaking through to a “first in market” position…Exactech, Inc. has reported the first implantations of its new porous metal acetabular system and novel surgical technique designed to improve the initial stability and long-term biological fixation of hip replacement implants.
Significant innovations in porous material, implant and instrumentation designs enhance the Novation Crown Cup system for primary, complex primary and revision hip arthroplasties. Exactech’s third generation porous material, InteGrip, is manufactured with a titanium alloy through a unique manufacturing method known as Electron Beam Melting. Exactech indicates that it is the first U.S. orthopedic device company to offer FDA-cleared orthopedic implants manufactured through this proprietary process.
Andrew Glassman, M.D. at The Ohio State University Medical Center, Columbus, Ohio, and David Covall, M.D. at Northside Hospital-Forsyth, Atlanta, Georgia, performed the first cases and report excellent experience with the new implants and instrumentation. Exactech says that the Novation system is innovative because its instrumentation offers a precision rasping technique that not only preserves bone but also allows the surgeon to efficiently prepare the augment site and create a stable trial construct that mimics the final implant stability.
“Augment site preparation is usually more difficult than this,” Dr. Glassman said, speaking to the simplicity of the technique, in the September 20, 2011 news release. During the surgery, Glassman noted that the scratch-fit and stability felt as good as the tantalum cup commonly used for complex and primary revision surgeries.
Dr. Covall reported that he was able to provide his patient solid implant fixation despite the patient’s poor bone quality. Covall also suggested that the simplified technique may provide a safer, more bone-preserving method of achieving implant stability, compared to the alternative practice of using large acetabular implants and allows the surgeon to more accurately replicate the natural hip center location.
Gary Miller, Ph.D., executive VP of research and development for Exactech, told OTW,
We had recognized at the outset of the program that constructing porous metallic components with such complex geometries and material property requirements would be challenging. Seeing the final prototypes meet our goals using this enabling technology was a major milestone for the team. Completing the successful early clinical evaluation confirmed the merits of a unified surgical technique and implant design using this unique manufacturing process.
Exactech officials report that the initial launch of the new system, featuring acetabular cups and augments, is underway in the U.S., with full, global market availability ramping up through 2012.