Consumer groups urge FDA to rescind 510(k) clearance for Aptus endostapler

February 29, 2012 by MassDevice staff

A coalition of patient safety advocates protests the FDA's clearance of Aptus Endosystems' graft endostapling system, calling for more strict standards of safety and effectiveness review for it and other life-saving implants.

Aptus Endosystems HeliFX

A group of consumer advocates demanded that the FDA heighten testing requirements for certain medical devices, taking exception to the agency's 510(k) clearance of Aptus Endosystems Inc.'s HeliFX endostapling system.

In a letter to FDA commissioner Dr. Margaret Hamburg, a coalition of 12 patient safety groups expressed their concern that the de novo pathway, intended for moderate-risk products with no substantial equivalents already on the market, was inappropriately used for higher-risk products – like the HeliFX – that should have gone though the more rigorous pre-market approval process.

Although not at odds with the de novo system itself, the troup argued that the HeliFX system, categorized as a Class III device and designed to fix leaks and migration in implanted endografts, circumvented the more appropriate and stringent PMA pathway by claiming to be something it isn't.

Sign up to get our free newsletters delivered straight to your inbox

"FDA has responded to the Institute of Medicine's recommendation by starting to beef up the de novo process, but instead of selecting a moderate-risk device, as the law requires, the FDA inappropriately used the de novo review process for a device that is obviously intended to save lives," Dr. Diana Zuckerman, of the National Research Center for Women & Families, one of the signers of the letter, said in prepared remarks. "To get around the law, the FDA is claiming that the product is not life-saving and therefore does not need to be tested by rigorous clinical trials and inspections, as is required for life-saving devices."