) to underperform from neutral.
Analyst Jason Mills says Edwards Lifesciences has halted enrollment in U.S. percutaneous aortic valve feasibility trials, admitting that the current delivery method (antegrade) has resulted in increasing complications, including some deaths.
He notes Edwards Lifesciences said it expects to restart U.S. enrollment in feasibility trials with new delivery method/catheter (retrograde) by the end of 2005. However, he still thinks FDA approval within four years, as the company expects, is unlikely.
Mills is concerned about growing tissue heart valve competition in U.S. He sees more than a 10% downside risk in Edwards Lifesciences over the next 12 months.