Meril's recently CE-approved MeRes100, used for the treatment of de-novo coronary artery lesions, has demonstrated zero scaffold thrombosis and very low Major Adverse Cardiac Event (MACE) rate of 1.87% at three years as shown in MeRes-1 and 1.61% in MeRes-1 Extend at two years.
“First generation bioresorbable scaffolds have not shown the most favourable results at long term. MeRes100, a next generation bioresorbable scaffold, has been developed with reduced strut thickness, an improved profile for better deliverability, faster degradation and possibly lower scaffold thrombosis,” said principal investigator for the MeRes-1 trial Dr Ashok Seth, Chairman of Fortis Escorts Heart Institute in New Delhi, India.
Long-term three-year follow-up data of the MeRes-1 first in-human study, published in EuroIntervention1, demonstrated the high efficacy of MeRes100 BRS with multimodality imaging at two years including:
Low late lumen loss (0.24±0.34mm) with quantitative coronary angiography (QCA)
Virtually complete strut coverage (99.24%) with optical coherence tomography (OCT)
Sustained mean flow area and very low percentage volume obstruction (7.5%) with intravascular ultrasound (IVUS)
Two-year data from this global study, which enrolled patients from Brazil, Europe and Asia, demonstrated relatively low late lumen loss (0.18±0.31mm) with a serial QCA analysis at six-month follow-up suggesting high efficacy on inhibiting NIH at late follow-up, and a sustained mean flow area and virtually complete strut coverage (97.9±3.7) shown in an OCT subset analysis at six months.
“The encouraging results from MeRes100 BRS are changing the way we currently view bioresorbable scaffolds,” said Dr Ashok Thakkar, Head Clinical Research at Meril Life Sciences. “We are aiming to continue further developing the clinical evidence of this next generation technology against a drug-eluting stent in a randomised setting in due course.”
Source: Company Press Release