Exactech Receives FDA 510(k) Clearance for Vantage™ Total Ankle
April 25 2016 - 9:20AM
Business Wire
Clearance Marks Company’s Latest Product
Development in Extremities Line
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.
About Exactech
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.
An investment profile on Exactech may be found at
http://www.hawkassociates.com/profile/exac.cfm. To receive future
releases in e-mail alerts, sign up at
http://www.hawkassociates.com/about/alert.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160425005831/en/
Exactech Inc.Investor contactsJody Phillips,
352-377-1140Executive Vice President of Finance &Chief
Financial OfficerorHawk AssociatesJulie Marshall or Frank Hawkins,
305-451-1888EXAC@hawkassociates.comorMedia contactPriscilla
Bennett, 352-377-1140Vice President, Corporate & Marketing
Communication
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