Device Dossier

SeQuent Please NEO - Coronary angioplasty balloon catheter, drug-eluting

Device Dossier for SeQuent Please NEO - Coronary angioplasty balloon catheter, drug-eluting (Coronary angioplasty balloon catheter, drug-eluting, Class…

Intended purpose

PTCA catheter, paclitaxel coated balloon catheter for percutaneous transluminal coronary angioplasty. Indicated for de novo lesions (primary use in the case of stenosis orocclusion including small vessels (SVD), residual stenosis after balloon or stent PTCA (ISR), pre & post dilation during coronary stent implantation and acute or impending vascular occlusion.

Functional description

SeQuent Please NEO is a drug-coated rapid exchange balloon catheter for percutaneous transluminal coronary angioplasty (PTCA). It involves the combination of mechanical widening of narrowed coronary arteries with the option of a pharmacologically supported prolongation of patency. The expansion of the balloon causes a surface contact of the coated balloon with those vessel segments which should be treated. This process allows the transfer of the drug into the vessel wall.

TGA Public Summary