Article preview from "The Gray Sheet" - September 8, 2010
Standard balloon-tipped angioplasty catheters can enter the market through the 510(k) clearance process, rather than the PMA route, beginning next month.
Balloon Angioplasty Catheters Gain Quicker Path To Market Under FDA Rule
By Jessica Bylander
Standard balloon-tipped angioplasty catheters can enter the market through the 510(k) clearance process, rather than the PMA route, beginning next month.
A Sept. 8 FDA final rule downclassifies standard percutaneous transluminal coronary angioplasty (PTCA) catheters from Class III to Class II with special controls.
Hundreds of versions of the ubiquitous devices, typically used in conjunction with stents to open clogged arteries, have entered the market via PMA or PMA supplement. Market leaders are Boston Scientific, Johnson & Johnson, Medtronic and Abbott.
FDA says it has received about 18 PMA supplements for PTCA catheters annually over the past five years. But no original PMAs for brand-new balloon-tipped coronary angioplasty catheters have been submitted during that period, the agency notes.
Whether the availability of the 510(k) route will attract more submissions remains to be seen. In addition to the reduced data requirements associated with 510(k)s, sponsors of new PTCA catheters would now pay a 510(k) fiscal 2010 user fee of $4,007, rather than the $217,787 for an original PMA.
PTCA catheters with plaque-cutting and scoring elements, such as AngioScore's AngioSculpt PTCA scoring catheter, however, remain Class III devices and require a PMA, FDA stresses.
Ten Years In The Making
FDA first announced its intention to down-regulate the devices in May 2008, well after device maker Cook Group submitted a reclassification petition to FDA in September 2000 ("The Gray Sheet" June 2, 2008).
The agency's Circulatory System Devices advisory panel recommended downclassification nearly a decade ago ("The Gray Sheet" Dec. 11, 2000).
FDA received no comments on the proposed downclassification.
Based on the panel recommendation and additional data reviewed since then, FDA is reclassifying balloon angioplasty catheters used for improving myocardial perfusion, for treating acute MI and in-stent restenosis and for post-deployment stent expansion.
An accompanying special controls guidance document includes requirements for biocompatibility and performance testing. Animal studies will only be needed for device designs that are notably different from marketed PTCA catheters, FDA says. And the 510(k) submissions for most new catheters will not require clinical data, the final rule adds.
FDA is not requiring additional post-market surveillance measures such as device tracking or post-approval studies.
The rule goes into effect for all products within the device category Oct. 8.
Cook Sought To "Make A Point"
Cook Group does not manufacture balloon coronary angioplasty catheters, though it does make balloon catheters for use in peripheral artery procedures. The firm has not ruled out future entry into the market, Steve Ferguson, chairman of Cook Group, said.
Ferguson explained in an interview that Cook sought downclassification of the balloon angioplasty technology "to make a point about the way we thought the regulation ought to work."
"Once a technology becomes known, it should be downclassified," Ferguson said.
"Once it becomes a well-known technology, or generic in the marketplace, or physicians are familiar with it, by all measures it ought to be downclassified rather than FDA having to spend tremendous resources on reviewing a PMA," he continued.
Ferguson urged FDA to use the process more frequently, and get reclassifications out the door more quickly. The device center has said it is beefing up investments in reclassification efforts, which includes both responding to third-party requests and addressing the two dozen or so preamendments devices that still need formal classification ("The Gray Sheet" April 7, 2009).
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