Device Dossier
IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter - Catheter, angioplasty, balloon dilatation
Device Dossier for IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon…
- GMDN category: Catheter, angioplasty, balloon dilatation
Intended purpose
The intended purpose of the IN.PACT Admiral DCB is to restore lumen patency and blood flow to peripheral arteries, previously stented peripheral arteries with in-stent restenosis, and native arteriovenous dialysis fistulae and to reduce the proliferative response associated with restenosis. The IN.PACT Admiral DCB is indicated for percutaneous transluminal angioplasty (PTA) in patients with denovo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries. The IN.PACT Admiral DCB with balloon lengths ≤ 150 mm is also indicated for patients with obstructive lesions of native arteriovenous dialysis fistulae.
Functional description
The IN.PACT Admiral is an Over the Wire (OTW) peripheral balloon catheter, specifically designed for percutaneous transluminal angioplasty in atherosclerotic obstructed vessels. The catheter has a dual lumen shaft. The double lumen shaft is branched at the proximal end so that one tube forms the entrance to the central lumen for the guide wire, while the other tube is used to inflate and deflate the dialation balloon with a mixture of contrast medium and saline solution.