Device Dossier

Prevail Paclitaxel-Coated PTCA Balloon Catheter - Coronary angioplasty balloon catheter, drug-eluting

Device Dossier for Prevail Paclitaxel-Coated PTCA Balloon Catheter - Coronary angioplasty balloon catheter, drug-eluting (Coronary angioplasty balloon…

Intended purpose

The Prevail DCB is intended to improve coronary luminal diameters of either single or multiple vessels, as an adjunct to coronary interventions and to reduce restenosis.

Functional description

The Prevail paclitaxel-coated PTCA balloon catheter is a percutaneous transluminal coronary angioplasty (PTCA) rapid-exchange system. The drug component consists of paclitaxel (approx. 3.5 μg/mm2) and the excipient urea. The balloon at the distal end of the catheter is inflated using an inflation device (attached to the proximal end). The catheter’s lumen allows a guidewire to position the catheter. Balloon markers enable placement. Shaft markers for brachial and femoral techniques are in place.

TGA Public Summary