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.
Read more: Renascent-III Trial