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Full U.S. release to begin in January.
August 13, 2014
By: Michael Barbella
Managing Editor
Officials at Exactech Inc. report the first implantation of the company’s Alteon tapered-wedge femoral stem. The surgery took place at Franciscan St. Francis Health in Carmel, Ind., and was performed by orthopedic surgeon Jeffery Pierson, M.D., a member of the design team for the new hip replacement implant. “It has been an incredibly gratifying experience to be directly involved in the design and development of a device that performed as well in surgery as I anticipated it would,“ said Pierson. “Clinically relevant improvements to devices, such as the ones we made with the new tapered-wedge stem, allow us to continue to provide the best standard of care to our patients.” Over the past two years, Pierson and Michael Kang, M.D., from the Insall-Scott-Kelly Institute in New York, N.Y., consulted with Exactech to bring to market a newly designed stem that addresses several clinical challenges that many surgeons face with current product design philosophies. The new stem, which is currently in the pilot launch phase of release, incorporates specific features designed to achieve axial and rotational mechanical stability between the lateral and medial cortices of the femoral canal, officials report. This product will expand to a limited number of additional sites within the coming months, and company officials report a full launch within the United States is expected to take place in January of 2015. The company received U.S. Food and Drug Administration 510(k) clearance for the Alteon stem in June. “We are pleased to provide this technology to patients who can benefit from the Alteon tapered-wedge stem,” said Exactech CEO David Petty. “This design philosophy represents about 40 percent of the market for cementless stems in the U.S. This new products gives us an opportunity to reach many more patients needing total hip replacement.” Based in Gainesville, Fla., Exactech develops orthopedic implant devices, related surgical instruments and biologic materials
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