Boston Scientific, a developer of interventional devices and products, has presented Evolve first human use trial study data results.
The non-inferiority, prospective, randomized, single-blind trial, which enrolled 291 patients, was designed to assess the non-inferiority of the Synergy Everolimus-Eluting Stent System compared to the Promus Element Everolimus-Eluting Stent System in treating de novo coronary artery lesions.
The Synergy stent features the proprietary platinum chromium alloy which uses a bioabsorbable PLGA polymer and everolimus drug combination to create an ultra-thin, uniform coating applied to the outer (abluminal) surface of the stent.
The stent technology is designed to provide faster and more complete vessel healing after stent implantation, which could reduce the duration of post-procedure dual antiplatelet therapy.
Monash Medical Centre MonashHeart director and trial principal investigator Ian Meredith said the Synergy Stent met the primary non-inferiority endpoint of six-month late loss compared to the Promus Element Stent, demonstrating effectiveness of drug elution from this abluminal bioabsorbable polymer.
"The platform also appears to be safe with very low rates of myocardial infarction and revascularization and no reported cardiac deaths or stent thrombosis," Meredith said.
The company said additional six-month angiographic outcomes for diameter stenosis and binary restenosis showed no statistical differences between the Synergy and Promus element stents.
Boston Scientific Cardiology, Rhythm and Vascular Groupsenior vice president CMO Keith Dawkins said Evolve trial data will be used to support CE Mark approval for Synergy, while additional larger studies are planned to further assess clinical event rates and the potential for reduced dual antiplatelet therapy with this stent technology.