News | Stents Bioresorbable | June 06, 2016

Amaranth Medical Completes Enrollment in RENASCENT-II Study

Study will evaluate 120-micron Aptitude sirolimus-eluting bioresorbable scaffold; company also announces RENASCENT III study of Magnitude scaffold

June 6, 2016 — Amaranth Medical announced that it completed enrollment in May in the RENASCENT-II study of its novel Aptitude 120-micron sirolimus-eluting bioresorbable scaffold (BRS). To date, no major peri-procedural complications have been recorded. Interim study results are expected to be presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting this fall. Amaranth plans to use data generated from this study as part of the application process for a CE Mark.

In addition, Amaranth announced plans to initiate the RENASCENT-III study of its fourth-generation Magnitude scaffold, which has a strut thickness in the sub-100-micron range, in the fourth quarter of 2016. This study will seek to enroll 70 patients with symptomatic coronary artery disease in multiple centers in Italy and Colombia (South America). Participants in RENASCENT-III will be evaluated at nine and 24 months and again at five years. Antonio Colombo, M.D., director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy and Juan F. Granada, M.D., executive director and chief innovation officer of the CRF-Skirball Center for Innovation, will act as co-primary investigators.

Each scaffold is designed to afford the strength of metal stents to assist the artery during the remodeling process following an interventional procedure, without leaving behind a permanent implant with inherent clinical limitations.

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