GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech Inc. (Nasdaq:EXAC), a developer and producer of bone and joint restoration products for extremities, knee, hip, spine and biologic materials, announced today it has received clearance from the U.S. Food and Drug Administration to market the Vantage™ Total Ankle to treat patients who suffer from arthritis in the ankle. The Vantage Total Ankle is the latest product in the company’s extremities line, and its first in the foot and ankle market.
“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, Exactech vice president of marketing for extremities. “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, MD, 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.”
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.
Exactech plans to initiate targeted clinical evaluation of the fixed-bearing Vantage Total Ankle this summer, with full-scale release scheduled for the first quarter of 2017.
Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech Inc. can be found at http://www.exac.com. Copies of Exactech’s press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.exac.com and http://www.hawkassociates.com.
This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.