Hong Kong-based OrbusNeich has enrolled the first patient in the Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) post-marketing registry.
The first patient has been implanted with the Combo dual therapy stent implant at the Amphia Hospital in Breda, the Netherlands.
The multicenter registry, which is designed to evaluate the long-term safety and effectiveness of the Combo stent in routine clinical practice, will enroll approximately 2,500 patients at up to 50 centers across Asia and Europe in a year.
Device-oriented target lesion failure is the primary endpoint of the study.
Apart from the MASCOT registry, the company is supporting the Combo stent with other clinical programs including the Reduce trial, which enrolled its first patient in June 2014 and aims to show the potential for a shorter period of dual antiplatelet therapy.
OrbusNeich president and COO Wayne Johnson said: "The initiation of MASCOT, our largest registry trial to date, represents the commitment we have made to really understand the patient benefits of the COMBO Stent.
"Only by delivering true vessel healing can patients feel safe for the long term. We expect the MASCOT trial to confirm what we have already seen with the COMBO Stent as it relates to vessel healing."
The Combo dual therapy stent helps in accelerating both endothelial coverage as well as control neo-intimal proliferation through the combination of the Pro-Healing Technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that is completely dissipated within 90 days.