Meril's MeRes100 Bioresorbable Vascular Scaffold Demonstrates 6-Month Safety and Efficacy

October 31, 2016—The MeRes-1 study was presented during the First Report Investigations presentations on bioresorbable stent technologies at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

Ashok Seth, MBBS, presented 6-month clinical, angiographic, intravenous ultrasound (IVUS), and optical coherence tomography (OCT) results from the first-in-man study of the MeRes100 (Meril Life Sciences Pvt Ltd.), a low-profile, 100-µm-thin strut, poly-L-lactide–based, sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with coronary artery disease.

The data demonstrated that the MeRes100 was both safe and effective with no major adverse cardiac events (MACE) at 6 months.

As summarized in the TCT announcement, the prospective, multicenter, single-arm trial enrolled 108 patients (116 lesions) at 16 Indian sites from May 2015 to April 2016. The primary endpoint was the 6-month rate of MACE—a composite of cardiac death, myocardial infarction, ischemia driven target lesion revascularization, and ischemia-driven target vessel revascularization. The secondary endpoint was scaffold thrombosis at 6 months.

The study found no MACE or stent thrombosis after the deployment of the scaffold up to 6-month follow-up. Quantitative coronary analysis data at 6 months demonstrated very favorable in-scaffold late lumen loss of 0.15 ± 0.26 mm. IVUS and OCT analysis showed no scaffold recoil and near complete strut coverage (99.3%) with neointima.

Dr. Seth commented in the TCT announcement, “The innovative design of the MeRes100 scaffold developed in India addresses some of the limitations of currently available BRS. The MeRes-1 first-in-man study demonstrates that this new generation thinner-strut sirolimus-eluting BRS is safe and effective at 6 months. These encouraging results provide the basis for further studies using a wider range of length and sizes in more complex and larger patient population moving to a randomized pivotal trial against the second-generation metallic drug-eluting stents by mid 2017.”

In the press release for the First Report presentations, the TCT conference co-director Ajay Kirtane, MD, stated, “Bioresorbable stents have the potential to be greatly impactful in the treatment of coronary artery disease, and it is exciting to see these first report investigations of several new and novel stents advancing the technology forward. These results give us the first insights into their safety and efficacy, but larger randomized trials are necessary in order to establish their role in clinical practice.”