Edwards Lifesciences Pauses Transcatheter Mitral Valve Study to Work Out Design Issues

In a call with investors, Edwards remained vague about the design complication, but was optimistic the trial will continue.

A feasibility study testing the CardiAQ transcatheter mitral valve replacement therapy has suspended clinical enrollment, according to device maker Edwards Lifesciences.

The company announced the pause in enrollment during an earnings call last week. Speaking with investors, Chairman and CEO Michael Mussallem said Edwards is “implementing key clinical learnings” from the feasibility study and has paused the trial to “perform design validation testing on a feature of our valve.”

During the call, the company declined to provide details, saying only that the temporary halting of the CardiAQ feasibility study is voluntary, something it is doing to ensure comfort when moving forward in ongoing and future studies. In addition, company officials stated they are focused on transseptal delivery of the mitral valve.

The company also emphasized it has only paused clinical enrollment in the feasibility study and not the whole program. The stoppage, however, delays the start of the European study designed for CE mark approval.

“[W]e're on a steep learning curve and to place a valve in the mitral position is a tough task and to do it well,” said Mussallem. “The valves are large. The pressures are high. The anatomy is very complex. There are very serious imaging challenges. There's coagulation challenges. And so we're on a steep learning curve and we're very pleased at the pace that we're moving at. We just decided on this feature that we were going to pause this while we're going through our own internal tests.”

The company said it is optimistic the results will be positive and enrollment will continue in the second quarter of 2017. To acquire the transcatheter mitral valve, Edwards purchased CardiAQ Valve Technologies in 2015 for $350 million. Edwards has a second transcatheter mitral valve replacement in clinical testing, one that also suffered an early setback. In 2015, the company halted the first-in-man trial with the Fortis after reports of valve thrombosis.

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