Device Dossier
SeQuent Please - Coronary angioplasty balloon catheter, drug-eluting
Device Dossier for SeQuent Please - Coronary angioplasty balloon catheter, drug-eluting (Coronary angioplasty balloon catheter, drug-eluting, Class III,…
- 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 or occlusion 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 is a PTCA balloon coated with paclitaxel containing matrix. The device is intended to improve lumen diameter and reduce re-stenosis in the treatment of lesions in native coronary arteries. It can be used alone or in conjunction with a bare metal stent. The paclitexel is intended to penetrate the tissue and minimise vessel (tissue) cell proliferation and helps prevent restenotic occlusion of the diseased vessel. Paclitexel is released when the balloon is inflated.