Wright Medical Receives FDA Approval for Conserve Plus Hip Resurfacing Device
BY LAUREN UZDIENSKI, NOVEMBER 10, 2009
Wright Medical announced that their Conserve Plus hip resurfacing device received long-awaited FDA approval, which the company said was supported by clinical data on over 1,300 patients with up to eight years of follow-up. The company plans to initiate surgeon training on the device immediately.
The PMA was first submitted in 2004, and since then the device has received regulatory approval in several OUS markets. Wright Medical has also introduced several design modifications in those markets, which the company can now begin to integrate in the U.S. version of the device via a PMA supplement.
Hip resurfacing is a bone-conserving alternative to a total hip, targeted at younger, more active patients, though the promise of resurfacing may have faded a bit since Wright submitted their Conserve Plus PMA. Surgeons who perform the procedure note its steep learning curve, and several studies have questioned its efficacy. Stryker and Smith & Nephew, the two companies who have hip resurfacing systems on the market in the U.S., have reported slower-than-anticipated demand for the devices, though that could be tied to macroeconomic factors.
