Wright Medical received clearance from the FDA to bring to market the CONSERVE® Plus Total Hip Resurfacing System. Particularly appealing to younger, active patients, the Conserve Plus is designed as a potential alternative to traditional total hip replacement with the goal of saving as much bone tissue as possible.
The approval permits Wright to market CONSERVE® Plus in the original femoral and acetabular component configuration specified in its PreMarket Approval (PMA) application and enables the Company to initiate efforts to introduce additional enhancements to the system which are currently only available outside of the United States.
The CONSERVE® Plus system is designed to offer pain relief and restoration of function while retaining as much healthy bone as possible and preserving future surgery options, including a primary total hip replacement.
The approval follows a successful clinical trial involving more than 1,300 patients, including those enrolled under Continued Access protocols, providing patient data of CONSERVE® Plus clinical data in postoperative periods of up to eight years in length. Wright will commence surgeon training in the first phase of its U.S. introduction.
To date, the overall survivorship of CONSERVE® PLUS implants is 97%. Almost all the patients enrolled in the study have returned to their active lifestyles without pain.
Press release: Wright Medical Group, Inc. Receives FDA Approval to Market CONSERVE(R) Plus Total Hip Resurfacing System…
Product page: CONSERVE Plus Total Hip Resurfacing System…
Flashbacks: Birmingham Hip, or How to Sell Fresh Hips to Boomers ; iUni Resurfacing Knee Approved in US, Now Goes to Europe; Cormet™ Hip Resurfacing System; Personalized Bicompartmental Knee Resurfacing System from ConforMIS Gets CE Mark
