Edwards Lifesciences launched its next-generation transfemoral delivery system, RetroFlex II, for the Edwards Sapien transcatheter heart valve at EuroPCR 2008 this week in Barcelona, Spain.
The RetroFlex II delivery system retains many features of the RetroFlex delivery system, and adds a tapered nose cone that facilitates the passage of the valve delivery catheter over the curve of the aortic arch and through the patient's native, diseased aortic heart valve., according to the Irvine, Calif.-based Edwards. The company said its new delivery system is designed to improve access during the transcatheter aortic valve replacement procedure.
The Edwards Sapien transcatheter heart valve, the RetroFlex delivery system, the RetroFlex II delivery system and the Monarc system are investigational devices and are not available for sale in the U.S. The Sapien transcatheter heart valve and the RetroFlex delivery system are being evaluated in a U.S. pivotal clinical trial, the company said.