Exactech: FDA Green Light to Market

“Market away, ” says the FDA to Exactech, Inc. The company has officially received clearance from the regulatory body to market the Vantage Total Ankle to those with ankle arthritis.

“With the introduction of the Vantage Ankle, Exactech continues its precedent of innovation in the extremities market, which began with our industry-leading Equinoxe platform shoulder system, ” said Darin Johnson, vice president of marketing for extremities, in the April 21, 2016 news release. “The ankle market is in need of advances in total ankle technologies. We have had the pleasure of working with a world-class design team that includes surgeons who have dedicated their careers to treatment of the ankle. Together, we have developed an implant that we believe will be an improvement for patients who need a total ankle.”

“I am impressed with Exactech’s ability to convert concepts from their other successful total joint replacement systems, ” said Mark Easley, M.D., design team member and president of the American Orthopaedic Foot and Ankle Society. “The company’s engineers have successfully turned our ideas into an exciting new treatment option for end-stage ankle arthritis. On behalf of the design team and engineers, I look forward to sharing the Vantage ankle with other surgeons so their patients may benefit from this meaningful new technology.”

As indicated in the news release, “Designed to conserve bone, the Vantage Total Ankle is an easy-to-use solution that allows for both stability and mobility in total ankle arthroplasty. The curved surface talar component is engineered to fit the anatomy of the diseased talus and restore the joint line, and both the curved talus and anatomic tibia designs are intended to improve implant stability and return anatomic kinematics. The system incorporates the signature press-fit bone cage design used in the Equinoxe shoulder system, developed to allow for initial and long-term fixation.”

Johnson told OTW, “The most significant challenge in designing an ankle to be bone conserving was the limited amount of exposure or space a surgeon has to work within the ankle, coupled with the lack of available biomechanical and anatomical data publicly available on the ankle.”

“Our internal expertise with 3D printing allowed us to rapidly trial myriad instrumentation advances in cadavers to maximize the limited space. And we aligned with a team of surgeons who have studied total ankles, ankle anatomy and biomechanics for their entire careers and tapped in to their proprietary expertise and data to develop an anatomic solution we believe will demonstrably improve outcomes for patients.”