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…
- GMDN category: Coronary angioplasty balloon catheter, drug-eluting
- Sponsor: B Braun
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.