Exactech Receives 510(k) Clearance for Computer-Assisted Shoulder Arthroplasty Technology
May 15 2017 - 10:52AM
Business Wire
ExactechGPS® Shoulder Application showcased
in two live surgeries to more than 150 shoulder specialists at
recent Masters Course
Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone
and joint restoration products and biologic solutions for
extremities, knee and hip, announced today it has received
clearance from the U.S. Food and Drug Administration to market the
ExactechGPS® Shoulder Application. Combining preoperative planning
with computer-assisted surgery, the industry-leading technology
allows for greater intraoperative visibility in both standard and
challenging shoulder arthroplasty.
“The ExactechGPS Shoulder Application offers groundbreaking
technology that is unique to the industry and should continue our
selling momentum that delivered 21% growth in the first quarter,”
said Darin Johnson, Vice President, Extremities Marketing.
“Allowing surgeons to preoperatively plan the surgery and then
execute it with a computer-assisted solution will help patients by
ultimately improving outcomes. Importantly, it also reflects
Exactech’s philosophy of keeping intraoperative decision making and
control in the surgeon’s hands.”
An introduction to the new technology was the focal point at the
recent 2017 Exactech Shoulder Masters Course, with live broadcasts
of two surgeries performed by Pierre-Henri Flurin, MD, in Bordeaux,
France.
“The live surgeries featuring the new ExactechGPS shoulder
application for both anatomic and reverse total shoulder cases were
incredible as it felt like we were in the operating room. It was
exciting to witness the most advanced innovation in shoulder
arthroplasty since reverse shoulders were first introduced,” said
attendee Samuel Antuña, MD.
Setting a new standard in medical education, the Masters
Course’s comprehensive scientific program featured 35 presentations
by distinguished faculty who shared their experiences and
philosophies with more than 150 surgeons from 17 countries around
the world. Faculty member Joseph Zuckerman, MD, said, “This was one
of the highest quality educational meetings I have participated in
during my professional career. Between the scientific and technical
presentations, debates, live surgeries and interactions between our
surgeon peers, it was a truly unique and rewarding experience.”
The ExactechGPS Shoulder Application’s preoperative planning
tool is designed to help surgeons understand their patient’s
anatomy prior to surgery. Intraoperatively, ExactechGPS provides
visibility into the glenoid vault in real time and allows for
consistent, accurate glenoid placement.1 A recent study showed that
more accurate glenoid placement minimizes complications and
theoretically increases implant survivability.2 In addition,
ExactechGPS provides a real-time view of retroversion and
inclination, reaming and drilling depth, screw placement and the
ability to adjust surgical plan intraoperatively, offering surgeons
more flexibility.
The ExactechGPS Shoulder Application has been used successfully
in the U.K., Spain, France and Australia. The initial launch in the
U.S. is planned for this quarter. It is the latest addition to the
Equinoxe® Shoulder System, which has been one of the fastest
growing shoulder lines on the market since its introduction more
than a decade ago. This year marks the 10th anniversary of the
first implantation of the Equinoxe reverse shoulder; Equinoxe
products will be implanted in the 100,000th patient before the end
of this year.
- Data on file at Exactech*
- Walch G et al. Results of a
convex-back cemented keeled glenoid component in primary
osteoarthritis: multicenter study with a follow-up greater than 5
years. J. Shoulder and Elbow Surg. (2011) 20; 385-394.
* In vitro (bench) test results may not necessarily be
indicative of clinical performance.
About ExactechGPS
ExactechGPS combines surgeon expertise with an advanced computer
system to perform the patient’s surgery with a goal of improved
accuracy and precision. Personalized for a patient’s unique bone
structure and anatomy, ExactechGPS is designed to allow surgeons to
decide where to remove bone and place the implant in the optimal
position. Exactech first introduced ExactechGPS to surgeons in the
United States for total knee arthroplasty, and has since broadened
its reach by providing medical education and supporting surgeries
in more than 11 countries. The technology has steadily gained
market acceptance and worldwide reach.
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 can be found
at http://www.exac.com.
A current investment profile on Exactech (Nasdaq: EXAC) is
available online at http://www.hawkassociates.com/profile/exac.cfm.
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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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Exactech Inc.Investor contactsJody Phillips,
352-377-1140Executive Vice President of Finance & Chief
Financial OfficerorHawk AssociatesJulie Marshall or Frank Hawkins,
305-451-1888EXAC@hawkassociates.comorExactechMedia
contactsPriscilla Bennett, 352-377-1140Vice President, Corporate
& Marketing Communication
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