Product Name: Cilotax™ Dual Drug Eluting Coronary Stent System
Device description : Cilotax™ Dual Drug Eluting Coronary Stent System is designed to treat coronary artery disease by opening clogged arteris and restoring blood flow. The stent provides support to the artery after angioplasty. The system also release medication to limit excess cell growth while artery heals.
This system consists of four subsystems.
A. Active Drugs – Paclitaxel & Cilostazol
B. Drug eluting Polymer system
C. Bare metal stent – a pre mounted L605 cobalt chromium alloy based stent.
D. Delivery system (Blackhawk ™ PTCA stent delivery balloon catheter)
? Indication for Use : The Cilotax™ is indicated for improving coronary luminal diameter and reducing restenosis in patients with symptomatic ischemic heart disease in de novo coronary artery lesions in native coronary arteries with a reference vessel diameter 2.25mm to 4.0mm
? Intended use: The Cilotax™ is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter 2.25mm to 4.0mm.
This system is intended to improve coronary luminal diameters as an adjunct to coronary interventions and reduce restenosis. The stents are intended as permanently devices.
- Active drug A : Paclitaxel “Anti-proliferative effect makes Lower restenosis”
- Active drug B : Cilostazol “Anti-platelet effect makes Lower stent thrombosis”
Cilostazol have potential synergism with Paclitaxel
- Drug eluting biodegradable polymer system
- Greater tissue penetration
- Longer residency and better release kinetic
- Proven performance of drugs (Paclitaxel & Cilostazol) and drug eluting polymer system supported by the rigor of the CILOTAX clinical program
- L605 Cobalt chromium alloy based stent is thinner (strut thickness 0.0035 inch), Stronger and more Biocompatible than 316L Stainless Steel stent and also provides the foundation for improved clinical outcomes.
- Thin struts and enhanced stent delivery system improve deliverability
- High radial strength, low recoil
- Excellent Stent retention even through the most tortuous vessels
- Exceptional flexibility and uniform scaffolding
- Ultra low profile balloon with flexible bonds
- Trifold balloon with memory, excellent re-wrap and firm stent retention