WIRE)–Wright Medical Group, Inc., a global orthopaedic
medical device company, today announced the 510(k) clearance and limited launch
of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides for total
ankle replacement. Designed for use with the Companys INBONE® Total Ankle
Replacement Systems, the PROPHECY® INBONE® Pre-Operative Navigation Alignment
Guides are now available in select sites in the U.S. through Wright Medicals
specialized foot and ankle sales force. Full U.S. commercial release is
anticipated to take place in the second half of 2012.
The PROPHECY® INBONE® Pre-Operative Navigation Alignment
Guides, along with the INBONE® Total Ankle Replacement Systems and other
orthopaedic product solutions, will be on display at Wrights exhibit booth
(#1945) from February 8 to February 10 at the American
Academy of Orthopaedic Surgeons (AAOS)
2012 Annual Meeting taking place at the Moscone
Convention Center in San Francisco.
Initially developed by Wright Medical for total knee
replacement, the PROPHECY® Pre-Operative Navigation Alignment Technology
utilizes computed tomography (CT) scans to create patient-specific ankle
alignment guides that facilitate the surgeons ability to precisely size, place
and align the INBONE® Total Ankle Replacement components during surgery.
Gregory Berlet, MD, a foot and ankle surgeon with the Orthopedic Foot & Ankle
Center in Columbus, Ohio,
performed the first surgical procedure using the new system. “The PROPHECY®
INBONE® Pre-Operative Navigation Alignment Guides enable me to accurately
position the INBONE® Total Ankle Replacement components while providing
predictable implant alignment from case to case,” stated Dr. Berlet.
“With this new addition to our growing suite of foot and
ankle products, surgeons now have a visual plan that details implant placement
in advance of the actual surgery, which can reduce the amount of standard
instrumentation required in the operating room and streamline the surgical
procedure,” said Robert Palmisano, President and Chief Executive Officer. “We
are committed to developing innovative devices to improve patients quality of
life, as well as surgeons experiences while they operate.”
With an estimated 4,000 procedures¹ expected to occur in the
United States in 2012, total
ankle replacement represents a growing market opportunity to treat the
approximately 50,000 people per year in the U.S. who experience severe ankle
pain due to end-stage ankle arthritis. Today, approximately half of these
patients are treated with ankle fusion, but advances in implant design have
made ankle replacement a feasible surgical option for many people. In addition
to providing pain relief, ankle replacements can offer patients better mobility
compared to fusion.
More information on Wright Medicals foot and ankle
products, including the PROPHECY® INBONE® Pre-Operative Navigation Alignment
Guides and the INBONE® Total Ankle Replacement Systems, can be found at www.wmt.com/footandankle/.
About Wright Medical
Wright Medical Group, Inc. is a global orthopaedic medical device company and a
leading provider of surgical solutions for the foot and ankle market. The
Company specializes in the design, manufacture and marketing of devices and
biologic products for extremity, hip and knee repair and reconstruction. The
Company has been in business for more than 60 years and markets its products in
over 60 countries worldwide. For more information about Wright Medical, visit
the Companys website at www.wright.com.
1. “2011 US Markets for Orthopedic Extremity Devices,”
published October 2010 by Millennium Research Group, Inc.