Device Dossier

Pantera Lux - Coronary angioplasty balloon catheter, drug-eluting

Device Dossier for Pantera Lux - Coronary angioplasty balloon catheter, drug-eluting (Coronary angioplasty balloon catheter, drug-eluting, Class III,…

Intended purpose

The Pantera Lux catheter is indicated for balloon dilatation of coronary arteries with a vessel diameter from 2.0 mm – 4.0 mm for the purpose of improving myocardial perfusion in (A) in-stent restenosis, (B) de-novo lesions, (C) acute or impending vascular occlusion and (D) treatment of small vessel disease.

Functional description

Paclitaxel releasing PTCA balloon catheter coated with 3 ug/mm2 of Paclitaxel on the balloon surface. Paclitaxel is delivered to the vessel wall upon balloon expansion. The dilatation balloon can inflate to a known diameter and length at recommended inflation pressures. Two radiopaque balloon markers (at the balloon’s proximal and distal ends) facilitate fluoroscopic visualization and catheter positioning. The catheter’s proximal end has a female Luer-Lock port to inflate/deflate the balloon.

TGA Public Summary