PTCA Catheter Makers Told to Seek Advice on Testing

Manufacturers of percutaneous transluminal coronary angioplasty (PTCA) catheters should present their performance-testing protocols to the FDA before conducting tests, a new draft guidance says.

The agency will review and provide comments on the protocols, which must assess the worst-case conditions a device is likely to experience.

The agency recommends evaluating extreme device dimensions, tolerance, sizes and any other important device parameters. It also suggests examining the outer limits of physiologic variables, such as blood pressure, vascular compliance and anatomic types.

The draft guidance was developed to support the reclassification of certain PTCA catheters into Class II (special controls).

These devices are used for balloon expansion of coronary arteries or to treat bypass graft narrowing in patients with insufficient blood supply through the coronary arteries. The draft does not apply to cutting or scoring PTCA catheters.

The guidance says clinical studies will not be needed for most PTCA devices. It also gives labeling suggestions for contraindications, warnings, precautions and adverse effects.

The guidance, “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters,” is available at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0285-gdl.pdf.