Amaranth Medical, a privately held medical device company, announced the initiation of a clinical study of the Company’s latest-generation MAGNITUDE™ sirolimus-eluting bioresorbable scaffold (BRS) scaffold, which has a strut thickness in the sub-100-micron range. Dr. Antonio Colombo, director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy and Dr. Juan F. Granada, executive director and chief innovation officer of the CRF-Skirball Center for Innovation will serve as co-primary investigators.
“Cardiologists are really asking for thin-walled scaffolds displaying the performance, efficacy and safety profile of metallic drug eluting stents,” noted Dr. Juan F. Granada. “The introduction of devices with this profile could broaden the spectrum of treatment with fully bioresorbable scaffolds. Amaranth’s 115-micron APTITUDE™ scaffold and their next generation MAGNITUDE scaffold promise to achieve those objectives, as Amaranth’s thinner strut design has the potential to provide the perfect balance between deliverability, over-expansion capabilities and long-term mechanical stability.”
This study, called RENASCENT-III, will enroll approximately 70 patients with symptomatic coronary artery disease in centers in Italy and Colombia, South America. Following implantation of the MAGNITUDE scaffold, participants in will be evaluated at nine and 24 months and up to five years.
About Amaranth Medical
Amaranth Medical, Inc. is a medical device company which has created a novel technology platform for the development and manufacturing of fully bioresorbable scaffolds. The Company’s products include the 150-micron FORTITUDE® and 115-micron APTITUDE™, which have each completed patient enrollment in their respective studies; and the sub-100-micron MAGNITUDE™ scaffold, which began enrolling patients in the fourth quarter of 2016. Each are 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. Amaranth Medical is headquartered in Mountain View, California, and its research and manufacturing operations are located both in Singapore and at its Silicon Valley headquarters. Amaranth Medical is led by Kamal Ramzipoor, and its investors include Charter Life Sciences, Bio*One Capital, Philip Private Equity, DCP Management and Venstar Capital.
Corporate and Media Relations Contact: