Medical Device & Diagnostic Industry

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FDA to Keep Tabs on
Stent Grafts

FDA has added thoracic aortic aneurysm stent grafts to a list of devices that must be tracked, according to a final guidance released in August. The agency says that it has issued letters to all OEMs affected by the requirements.

“FDA has increased postmarket scrutiny of implanted devices, and wants to ensure that these devices are performing as described,” says Venkat Rajan, industry manager for medical devices at Frost & Sullivan. “After a series of device recalls in the cardiac rhythm management [sector] a few years ago, FDA has ramped up its surveillance of these devices.”

Federal law allows the agency to require tracking for Class II or Class III devices whose failure is likely to cause serious adverse health consequences. FDA also tracks devices that are implanted for more than a year or are life-supporting and used outside a device-user facility.

First-generation endovascular grafts were associated with clinical complications, which made vascular surgeons reluctant to use the devices. Some were even withdrawn from the market— which is now estimated at $400 million in the United States, Rajan says.

The agency’s move will force OEMs to be more diligent in follow-ups with

FDA’s tracking move will require manufacturers to pay more

attention to the de-

vice’s effects, accord-

ing to industry ana-

lyst Venkat Rajan.

clinicians and patients, but Rajan says that tracking requirements should not shake up the market for these devices.

“Ultimately, it should not have a significant effect unless a device malfunctions, resulting in a recall,” Rajan says. “Growth in the endovascular aneurysm repair sector will depend on how the next generation of [stent grafts] performs.” —Lawrence Lloyd