Scitech has announced that the Inspiron coronary sirolimus eluting stent has received CE mark approval. The device is a third generation drug eluting stent designed to create a fast and homogeneous endothelialisation.
According to a press release from Scitech, the device’s design, material (CoCr), thin struts (75μm) and delivery system gives it good navigability, flexibility, good crossover profile, moderate radiopacity and high balloon rupture pressure. Inspiron’s abluminal coating is composed of a mixture of PLA and PLGA polymers and a low Sirolimus dosage resulting in a moderate drug elution profile (60% in 10 days and 100% in 45 days), complete coating degradation between six and nine months and in a fast and homogeneous endothelialization.
“[The] Inspiron drug eluting stent has shown late lumen loss comparable with the most important global brands,” says Alexandre Abizaid, (Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil).
Preclinical and clinical studies have proven the efficacy and safety of the INSPIRON Drug-Eluting Stent, Scitech adds. The nine-month follow-up of the Destiny Trial, a multicentre, randomised study comparing Inspiron to a Biolimus-eluting stent, demonstrated noninferiority for in-stent late lumen loss. The OCT analysis showed a high strut coverage rate at nine months (99.49%), also corroborated by the REPAIR study (97% of the struts covered at three months).