The New York Times is reporting that Edwards Lifesciences is suspending “… a clinical trial of a method of replacing failing aortic heart valves without open heart surgery because “more than one” of the 10 patients in the trial died and others experienced serious complications.”
The press release from Edwards Lifesciences explains current difficulties with the delivery of Cribier-Edwards valve:
The company took this voluntary action after some U.S. antegrade cases demonstrated a greater degree of clinical complexity and adverse outcomes when compared to results of a Canadian study, where cases are being performed with a new retrograde delivery system. Data presented at the 2005 Paris Course on Revascularization in May indicated that the company’s custom retrograde delivery system resulted in positive clinical outcomes.
“We recently have completed a number of procedural refinements, including the development of a simpler and more direct retrograde delivery approach, which has led to more favorable clinical success rates and fewer complications,” said Stanton J. Rowe, Edwards’ corporate vice president, Percutaneous Valve Interventions. “Until we gain regulatory approval to allow this option in our trials, we have temporarily suspended U.S. patient enrollment.”
Edwards has notified the U.S. Food and Drug Administration of its plans, and simultaneously is working to obtain approvals for this delivery approach. The company believes it will be able to resume its feasibility trial later this year. Previously, Edwards had expected to complete the trial’s initial feasibility phase by the end of 2005…
“We remain confident about the potential of percutaneous heart valve therapies, which offer hope to thousands of patients worldwide who are not good candidates for conventional open-heart valve replacement surgery and face limited options,” Rowe said. “At the same time, this is breakthrough medical therapy, and we want to ensure that we provide this technology in a responsible way to patients suffering from debilitating aortic valve stenosis.”
The Cribier-Edwards Valve’s official page…