According to a SeekingAlpha transcript of an Edwards Lifesciences fourth-quarter 2016 earnings conference call, the company has put a halt on enrolment in its clinical trial of Cardiaq.
“We recently paused enrolment in our clinical trials to perform further design validation testing on a feature of our valve,” Michael A Mussallem said during the call. “If we see positive results from the test, we expect to resume clinical trial enrolment in the second quarter [of 2017]. This pause also postpones the start of our CE mark trial.”
According to the call, this was consistent with “clinical learnings” from the US feasibility study of the device. “It’s a bit of a signal of just how early this therapy is,” Mussallem said. “in every case [we learn] not only something about our device, [but] something about the procedure, something about imaging, and something about anticoagulation, and we are trying to apply all those learnings as we go.”
A press release entitled reporting Edwards’ financial results, released on 1st February—hours before the conference call—does not mention the Cardiaq issue.
Edwards LifeSciences purchased Cardiaq Valve Technologies in 2015.