Amaranth Medical, a medical device company developing next-generation bioresorbable scaffolds, provided an update on the company’s sirolimus-eluting bioresorbable scaffold (BRS) products at the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting during the following sessions:
Didactic Session: Drug-Eluting Stents, Bioresorbable Scaffolds, and Coronary Drug-Coated Balloons, Part 2, Session VII: Active BRS Programs. September 22nd from 4:34 pm-6:02 pm.
Keynote Interventional Studies Session: Drug-Eluting Stents, Bioresorbable Scaffolds, and Drug-Coated Balloons I. September 23rd from 8:00 am-9:00 am.
Satellite Symposium: Unveiling the Future of Bioresorbable Coronary Scaffolds: The Thin-Walled High Mechanical Performance Amaranth Medical BRS Program. September 23rd from 11:30 am-12:30 pm.
Antonio Colombo, MD, director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy and co-principal investigator of the RENASCENT studies, presented nine-month follow-up results of the 70 patients implanted with MAGNITUDE®, the company’s 98-micron BRS. Dr. Colombo noted, “At nine months, MAGNITUDE continues to perform clinically well and it sets a new standard for thin-strutted scaffold performance. The MAGNITUDE BRS displays similar mechanical performance compared to metallic drug-eluting stent (DES) not requiring changes in the implantation technique. We are approaching a new phase in the investigation of this device with plans to conduct a larger head-to-head comparative study against metallic DES.”
At their nine-month follow-up visit, patients who received the MAGNITUDE BRS in the international, multi-center RENASCENT III study experienced a low rate of peri-procedural major adverse cardiac events (2.9% MACE) and a binary restenosis rate of 4.5%. Optical coherence tomography (OCT) showed nearly complete strut coverage (97%) and low rate of strut malapposition (0.2%). In addition, metallic-stent-like scaffold area was observed after implantation and maintained at the nine-month follow-up visit, demonstrating sustainable mechanical stability.
Juan F. Granada, MD, co-principal investigator of the Amaranth studies, presented on the company’s wide range of scaffolds with progressively reduced strut thickness currently being evaluated in clinical trials. Dr. Granada also provided an update on DEFIANCE™, the world’s thinnest (85-micron) BRS. Dr. Granada commented, “Amaranth’s preclinical DEFIANCE results continue to demonstrate that miniaturization of strut thickness is technologically achievable without affecting mechanical performance. Reducing strut thickness to the 85-micron range has the potential to impact healing response and restenosis favorably and overcome the issues encountered with first generation BRS. I am eager to see this device tested in clinical trials soon.”
Three-year follow-up results, including safety and angiographic findings, from the clinical study of FORTITUDE®, Amaranth’s 150-micron BRS, and APTITUDE®, 115- micron BRS were presented at the company’s symposium by Alaide Chieffo, MD, the research director of the Interventional Cardiology Unit at Ospedale San Raffaele in Milan, Italy. These results demonstrate high clinical success rate, low MACE rate and almost complete strut coverage at nine months.
“I believe that the results we presented at TCT are indicative of the exponential leap forward that is only possible with Amaranth’s polymer technology, which is the foundation of all our BRS products. This technology enabled the significant clinical performance we are observing across the entire family of products from FORTITUDE (150-micron) to MAGNITUDE (98-micron). We expect to receive CE Mark for APTITUDE by the end of 2018 and MAGNITUDE by Q1, 2019 and are finalizing our plans for their eventual commercialization,” added Kamal Ramzipoor, CEO of Amaranth Medical. “This pioneering technology also enabled the development of a BRS with struts comparable in thickness to the current gold standard metal DES – a feat previously considered unachievable.”