NEW YORK (Reuters) - U.S. health regulators appear open to speeding up approvals of medical devices that currently often reach European markets three to five years ahead of being cleared in the United States, the chief executive officer of Edwards Lifesciences said.
Such a change could help get the third generation of its Sapien transcatheter aortic heart valve replacement (TAVR) to U.S. clinicians faster than previously expected, Edwards CEO Michael Mussallem told Reuters on Monday following the company’s business update for analysts and investors in New York.
“We’re very hungry for a friendlier innovation climate,” he said. “We think that the leadership of FDA on the device side is trying to really be more friendly to innovation.”
The Food and Drug Administration has heard the frustration from doctors who wonder why technology that’s being developed in the United States is not be available sooner for American citizens when they’re good, Mussallem said.
Devices can be approved in Europe as long as safety is established without going through the lengthy clinical trial process required by FDA.
“They really are being very thoughtful about trying to improve their performance and bring breakthrough technologies earlier,” Mussallem said of FDA leadership. “Our hope is that the vision that they’ve talked about...actually gets implemented.”
The FDA did not immediately provide a requested comment on the topic.
TAVR systems - Edwards’ most important growth driver - are used to replace diseased heart valves without the need for chest cracking open heart surgery. Each new version the company has developed has been smaller and easier to use than the prior iteration, but each much go through its own U.S. clinical trials process.
Edwards, the market leader, expects the global TAVR market to exceed $3 billion by 2019.
”Sapien 3 is performing at a very high level in Europe,“ the CEO said. ”Not only is its profile very small, but it appears to be able to reduce leak at a substantial rate, which is often associated with mortality, so this is a big deal.
“There is a great deal of anticipation from U.S. clinicians to get that,” Mussallem said.
The FDA has signaled a willingness to use 30-day results, rather than the usual one-year trial, for the company to demonstrate the device’s approvability, he said. If that proves to be the case, Edwards could file for approval within a month.
“So by early 2016,” he said, “that Sapien 3 has a possibility to come to the U.S.”
Reporting by Bill Berkrot; Editing by Alan Crosby