INSPIRON Coronary Sirolimus Eluting Stent from SCITECH Medical received CE Mark approval.
INSPIRON is a 3rd generation Drug Eluting Stent designed to create a fast and homogeneous endothelialization. Its design, material (CoCr), thin struts (75 μm) and delivery system gives it good navigability, flexibility, good crossover profile, moderate radiopacity and high balloon rupture pressure. Its 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 6 and 9 months and in a fast and homogeneous endothelialization. INSPIRON is a 3rd generation Drug Eluting Stent designed to create a fast and homogeneous endothelialization.
“Inspiron Drug Eluting Stent has shown late lumen loss comparable with the most important global brands” says Alexandre Abizaid, MD PhD.
Preclinical and clinical studies have proven the efficacy and safety of the INSPIRON Drug-Eluting Stent. The 9-month follow-up of Destiny Trial, a multicenter, randomized 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 9 months (99.49%), also corroborated by the REPAIR study (97% of the struts covered at 3 months).
SCITECH Medical is a minimally invasive medical device company that was founded over 15 years ago and is currently present in more than 40 countries. Its 6.000 sqm state-of-the-art ISO 13.485 certified facility is located in Brazil. Currently the company develops and manufactures a wide portfolio of products for the Interventional Cardiology, Peripheral Vascular, Endosurgery and Endoscopy markets.
For further information click here.