iVascular is pleased to announce that Angiolite coronary DES is now reimbursed in Belgium.
The obtention of this reimbursement is the first step into the introduction of the coronary products of iVascular in the country.
“We are excited to enter this market in the coronary area, with Angiolite which has proven in clinical trials its outstanding efficacy and safety profile” said Albert Jávega (Deputy manager of iVascular).
Angiolite is a sirolimus eluting coronary stent, indicated for patients with symptomatic ischemic heart disease due to “de novo” stenotic and re-stenotic lesions and patients with occlusive disease due to acute myocardial infarction.
Angiolite has been specifically designed to obtain excellent outcomes.
It is composed by alternating links to achieve a homogeneous arterial coverage with high rates of endothelialization due to its fluorinated polymer and TransferWise, proprietary iVascular nanotechnology.
Angiolite DES has an optimal radial force with minimal recoil providing the physicians with an outstanding arterial support and its strut thickness range adapts to the need of the arteries (75 µm) providing physicians with a great device. This DES is crimped with advance technology into a multilayer balloon and its catheter is coated with iVascular proprietary hydrophilic coating Hydrax plus.
Clinical evidence
Angiolite has proven its outstanding efficacy and safety profile in several studies such as:
ANGIOLITE Trial: This randomized clinical trial demonstrates the non-inferiority in anti-restenotic efficacy by similar LLL rates at midterm follow-up of the Angiolite SES vs an EES (0.04mm vs 0.08mm respectively).
Clinical endpoints were comparable between the groups at two-year follow-up.
ANCHOR trial: In ANCHOR, Angiolite demonstrated a favorable early healing profile assessed with OCT at 3 and 6-month post PCI.
This was characterized by high rates of strut coverage (86.3% at 3 months) and very low rates of in-stent LLL. 24-month clinical data characterized by the absence of binary in-stent restenosis, stent thrombosis and cardiac death, suggesting a highly efficacy of Angiolite.
RANGO Registry: All comers registry including high risk population showed very low rates of clinical events at 12-months FU.
The TLF was consistently low of 1.9% showing high efficacy, and ST of 0.6% showed a safety profile comparable with DES current in the market.
Learn more about Angiolite here.
