The news — which came yesterday with the company’s second-quarter earnings announcement — comes weeks after an urgent field safety notice in which the company warned customers that it had received reports of problems tracking and manipulating the Centera system around the aortic arch in specific cases.
Optimizing deliverability of the Centera system — on top of securing FDA approval of the Sapien 3 valve and Sapien 3 Ultra system for low surgical risk — would require a significant investment on the part of Edwards Lifesciences, said CEO Michael A. Mussallem.
“The way that valve delivers didn’t work as well in all anatomies as we would have liked,” Mussallem told analysts in an earnings call transcribed by Seeking Alpha.
On top of the delivery system challenges, the Centera trial Edwards was conducting would have only achieved an intermediate risk indication.
“So when we put that altogether and thought about where we’re going to apply the resources of our team and how much confidence we have in the existing platform and how excited we are on future platforms, it was a tough decision, but we made it and decided that we’re going to focus our resources on the next generations as well as the excitement we have around our existing platforms,” Mussallem said.
The Sapien 3 Ultra hasn’t been entirely trouble-free. In an undated field advisory, Edwards warned of a low risk of burst balloons during implantation, cautioning doctors to closely follow instructions for use to avoid the problem.