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Stent Systems

Drug Eluting Stent EFIL + Sirolimus Eluting Stent System

The EFIL+ Sirolimus Eluting Stent System is a combination product comprised of two regulated components: a device (a coronary stent system) and a drug product (a formulation of Sirolimus contained in a polymer coating) pre mounted on balloon catheter between two platinum iridium radio opaque marker bands. EFIL+ uses a validated formulation of low dose Sirolimus (1.30µg/mm ) timed to elute in ̴30 days to 45 days from a biodegradable & biocompatible polymer base (PLLA & PLGA) which degrades simultaneously

The stent platform is made of Cobalt Chromium Alloy L605, which contains no Molybdenum and only 10% of Nickel. After mounting stent onto a balloon catheter, it is deployed in the coronary artery by inflating the balloon. It is intended as a permanently implanted, non-reusable device. EFIL+ Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease in de novo coronary lesion in native coronary arteries with reference vessel diameter of 2.50 mm to 4.0 mm and a lesion length ≤ 36 mm.

Short Version of DES

The EFIL+ Sirolimus Eluting Stent System is a combination product comprised of two regulated components: a coronary stent system and a drug product  pre mounted on balloon catheter. It is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease in de novo coronary lesion in native coronary arteries.

TricValve®

TricValve® - Transcatheter Bicaval Valves System is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux.

Vienna Aortic

The Vienna Aortic Valve SE – Self-expandable Transcatheter Valve System is designed to treat severe aortic stenosis in patients at medium to high risk for open heart surgery.

PTCA Catheters

Three PTCA Catheters available: Kathy NC, Kathy SC, Kathy DC.

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