Life Sciences

FDA offers draft guidance on angioplasty catheters

Device Regulation Alert: Safety, Compliance and Reimbursement News, June 16, 2008

The FDA is reclassifying percutaneous transluminal coronary angioplasty catheters (PTCA) as Class II devices and issued draft guidance for satisfying the special control requirements applicable to them.
 
The guidance defines PTCA catheters as those made for “balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis” in patients with coronary ischemia to address myocardial perfusion, acute myocardial infarction, in-stent restenosis, and post-deployment stent expansion.
 
Once the reclassification is finalized, makers of PTCA catheters will need to address the risks and recommendations of the guidance in their 510(k) submissions or otherwise provide “equivalent assurances of safety and effectiveness of PTCAs.” That means such device manufacturers must:
  • Show their PTCA catheter device meets the general controls under the Federal Food, Drug, and Cosmetic Act
  • Address risks listed in the draft guidance
  • Get a substantial equivalence determination from the FDA before marketing their PTCA cathether device
The draft guidance does not apply to PTCA catheters that are not cutting or scoring PTCA catheters.
 
The following risks are associated with PTCA catheters:
  • Adverse tissue reactions
  • Device failure causing air embolism, stroke and other conditions
  • Vessel damage
  • Adverse interaction with other devices
  • Infections
  • Improper use such as over inflation of the balloon or use of excessive force in performing the procedure
Special controls in the guidance address these risks and include testing and labeling recommendations. The guidance and labeling requirements are intended to ensure proper use and performance of PTCA catheters. Post-market surveillance is also required to monitor for adverse events involving the devices.
           
The FDA invites public comments on the proposed reclassification of PTCA catheters to Class II devices and on the draft guidance concerning special controls for the device.

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