IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter - Peripheral angioplasty balloon catheter, drug-eluting

Intended purpose

The intended purpose of the IN.PACT 018 DCB device is to restore lumen patency and blood flow to peripheral arteries and previously stented peripheral arteries with in-stent restenosis, and to reduce the proliferative response associated with restenosis.

Functional description

The IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter is percutaneous transluminal angioplasty balloon catheter. The drug component consistent of paclitaxel and urea excipient. The balloon at the distal end of the catheter is inflated using an inflation device (attached to the proximal end). The catheter’s lumens allow for a guidewire to position the catheter and forms a passageway need for inflation/deflation. Markers are in-place to enable placement via femoral access.