Wright Medical Group, Inc. Announces 510(k) Clearance and Limited U.S. Launch of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides (press release)
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 Company’s 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 Medical’s specialized foot and ankle sales force. Full U.S. commercial release is anticipated to take place in the second half of 2012.
PROPHECY(R) INBONE(R) Pre-Operative Navigation Alignment Guides — First-To-Market Pre-Operative Alignment Technology for Total Ankle Replacement (Photo: Business Wire)
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 Wright’s exhibit booth (#1945) fromFebruary 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.