Edwards Lifesciences Corp. is delaying U.S. enrollment in a clinical trial for a new type of heart valve, the medical device maker said Monday.
The company said it is voluntarily pausing after complications, including death, were reported in fewer than 10 trial cases in Canada.
At issue is how the percutaneous, or less invasive, valve is inserted, according to Edwards. The company said it is pushing back U.S. trial enrollment so it could incorporate a new delivery system for the valve that’s being evaluated in Canada.
“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 Rowe, Edwards’ corporate vice president in charge of percutaneous valve interventions, in a release.
“Until we gain regulatory approval to allow this option in our trials, we have temporarily suspended U.S. patient enrollment,” Rowe said.
Edwards said it notified the Food and Drug Administration of its plans and is simultaneously working to obtain approvals for the retrograde delivery approach.
A retrograde approach involves delivering the valve directly to the patient’s native aortic valve through the patient’s main artery. By contrast, an antegrade approach that’s being used in Canada involves crossing the patient’s septum and mitral valve to reach the aortic valve.
Edwards said that it believed it would be able to resume its feasibility trial later this year, and that the news wasn’t expected to have a material impact
The news hit Edwards’ shares on Tuesday, sending them down 4% in early trading.
The percutaneious valve is Edwards entry into the market for less-invasive valves. Edwards is the leading maker of valves implanted during open-heart surgery with about a third of the market.
Edwards has said that it hopes to have complete U.S. approval for the less-invasive valve by 2007.
