This article is a collaboration between 51˶ and:
WASHINGTON -- FDA commissioner Robert Califf, MD, wants to make America great again ... for cardiovascular device development, that is.
The field has transformed, he said in a plenary talk here at the Transcatheter Cardiovascular Therapeutics meeting.
"I used to really enjoy making fun of interventional cardiologists as knuckle dragging individuals who didn't know much about anything except about how to work in the cath lab. It's amazing what's happened. You're now the paradigm of evidence generation."
However, despite the advances in high-quality clinical trial evidence, the early phases of device research in the U.S. have slowed.
"All of you know there has been an equilibrium between the U.S. and other parts of the world where to a large part the device industry, particularly in this arena, moved away from the U.S. in the early studies," he said. "The sentinel call came with percutaneous valve procedures. There was a prolonged delay between marketability in Europe and the United States.
"To the great credit of the community of investigators, practitioners, and patients, and much more work at the FDA, we now have a pathway smoothed called Early Feasibility Studies, which is bringing the industry back. And I want to really accelerate that, because we're hearing from a lot of people that they want to access the technology early -- it's the right thing to do. And we're hearing from industry that they would like to work in the U.S."
Califf urged the interventional cardiologists and vascular surgeons at the meeting to push their facilities to think beyond institutional outcome rates that could be impacted by participating in such studies.
"The main limiting factor at this point is the health systems that we're all working in," he said. "They're very risk averse. While it's nice to argue in advertising 'Our interventional cardiologists are the best in town' on a billboard, protecting those interventional cardiologists [to allow them to] do the high-risk studies that are really needed to develop devices is a different matter."
As the U.S. tries to move closer to the European system in terms of speed of access to devices, the E.U. is trying to shift toward the U.S. system in terms of safety and efficacy.
"Both the U.S. and E.U. are changing their systems to find that right balance between device innovation, timely patient access, and assuring those devices are safe and benefit patients," said session moderator director of the FDA's Center for Devices and Radiological Health.
In some regards, that slower approach -- waiting to initiate the U.S. trials until after the early evidence has been developed in Europe -- has protected U.S. patients, noted Alan G. Fraser, MD, who represents the European Society of Cardiology at the Medical Device Experts Group at the European Union.
He cited a recent key study in BMJ that compared the two regulatory systems on approvals of 309 high profile devices, three-quarters of which were in the cardiovascular field. For cardiovascular devices, there was an average of about 1-year lag between approval in Europe and approval in the U.S.
There was some evidence that early access translated to risk. One-third of the devices never were approved for the U.S. market, and those approved first in Europe had a . (27% versus 14%).
"In the United States, we've been in many ways as researchers and clinicians jealous of our European colleagues because they had such earlier access to exciting new technology, much of which did move the field forward..." agreed , of New York-Presbyterian Hospital/Columbia University Medical Center in New York City and director of TCT.
"On the other hand," he added as a discussion panelist, "we were also very comfortable with FDA approach to making sure there really was safety and effectiveness before hundreds of thousands or even millions of citizens of the United States were exposed to those devices. We also noted that many of the European devices didn't work, there was no evidence at least that they worked, and some were harmful."
Discussion panelist , who serves on Spain's Medicines and Healthcare Products Regulatory Agency, expressed doubt that Europe could ever move to a centralized approval agency for devices as it has for medicines.
Aside from fragmentation, which may be intractable, a problem with the European system that is being tackled is that devices currently are only required to achieve intended performance -- as defined by the manufacturer -- rather than effectiveness in order to be cleared for clinical use.
A proposal for revision of the E.U. standards for granting marketing authorization to medical devices released in June may help Europe achieve better balance in protecting patients, Fraser noted. It "comes close to effectiveness."