Amaranth Presented Interim Nine-Month Follow-up MAGNITUDE (98 micron) and Two-Year Follow-up APTITUDE (115 micron) Data at EuroPCR Symposium
– DEFIANCE, Amaranth’s 85-micron BRS, unveiled during 23 May Symposium –
MOUNTAIN VIEW, CA – May 23, 2018 – Amaranth Medical, a medical device company developing next-generation bioresorbable scaffolds for the interventional cardiology market, provided an update on the company’s sirolimus-eluting bioresorbable scaffold (BRS) products during a satellite symposium during EuroPCR 2018, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions. The symposium, entitled: The Future of Bioresorbable Coronary Scaffolds is here: The Thin-Walled High Mechanical Performance Amaranth Medical BRS Programme, was held on 23 May 2018 from 13:30 -14:30 CEST in room 242A / level 2.
Amaranth’s MAGNITUDE®, the world’s first 98-micron BRS to generate patient follow-up results in a clinical study, was a subject of discussion at the 23 May symposium. Clinical device success was high at 97.3% for the 70 patients in RENASCENT III, an international, multi-center study. An interim analysis of 48 patients nine months following their procedure revealed a low rate of major adverse cardiac events (6.3% MACE due to two cases of peri-procedural cardiac enzyme elevation) and a binary restenosis rate of 7.9%. To date, there have been no reported incidence of scaffold thrombosis. Strut apposition and coverage was present in the great majority (97%) of struts analyzed by optical coherence tomography (OCT) in the patients implanted with MAGNITUDE. Detailed nine-month imaging and safety data was presented at the symposium by Alaide Chieffo, MD, the research director of the Interventional Cardiology Unit at Ospedale San Raffaele in Milan, Italy.
Dr. Chieffo explained, “These RENASCENT III results are early in the patient follow-up window. Additional, larger clinical studies would be needed to confirm these findings. Even so, they are promising and speak to the capabilities of the Amaranth polymer technology to develop scaffolds that are thin and strong enough to rival metal stents.”
“At 98 microns, the MAGNITUDE scaffold has started to match the technical and mechanical performance of metallic drug-eluting metal stents (DES),” added Juan F. Granada, MD, president and CEO of the Cardiovascular Research Foundation and co-principal investigator of the Amaranth studies. “The thin struts on MAGNITUDE allow the easier navigation of the scaffold through more tortuous anatomies; its mechanical strength allows operators to use a more “conventional” deployment strategy.”
Amaranth’s EuroPCR symposium also included a presentation and discussion of the efficacy and safety findings from the 60-patient, multi-center, international RENASCENT II study of APTITUDE®, a BRS with a strut thickness of 115 microns. As previously reported, at nine months following implant, RENASCENT II patients showed a high clinical device success rate (98.3%) and no cases of restenosis or scaffold thrombosis. At nine months, OCT analysis showed nearly complete strut coverage (97.0%) and a low MACE rate of 3.4% (two non-Q wave myocardial infarctions related to non-target lesions). Dr. Chieffo presented new interim two-year follow-up results during the EuroPCR symposium, which show no additional MACE events and no incidence of scaffold thrombosis. The CE Mark for APTITUDE is expected to be received in 2018.
Included in the company’s update were new details about the 85-micron DEFIANCE™ scaffold, which is comparably sized to market-leading DES without the risks associated with a permanent implant. When a clinical study of DEFIANCE commences in 2019, it will have the thinnest struts of any bioresorbable scaffold ever tested in clinical development.
Antonio Colombo, MD, director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy and co-principal investigator of the RENASCENT studies, stated, “The prospect of a viable BRS with 85-micron struts - as thin as a DES - is unthinkable with the limitations of most polymer production techniques. If DEFIANCE produces clinical results comparable to Amaranth’s other pipeline products, it could be a truly unique offering.”
“There have been many failures in the development of BRS due to the limitations of first-generation polymer technology,” commented Kamal Ramzipoor, CEO of Amaranth Medical. “However, the benefits of a bioresorbable scaffold remain compelling and we believe will drive interest in our product line, especially in our thin-walled APTITUDE and two sub-100-micron scaffolds, MAGNITUDE and DEFIANCE. These BRS possess the desired characteristics to meet industry expectations of strength, flexibility and ease of use. We believe Amaranth is poised to become one of the few - if not the only - company with commercially viable sub-100-micron BRS.”
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® scaffold; 115-micron APTITUDE®, for which a CE Mark application has been submitted; the 98-micron MAGNITUDE®; and DEFIANCE™, an 85-micron scaffold that is expected to enter clinical studies in 2019. 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 Boston Scientific, Charter Life Sciences, Bio*One Capital, Philip Private Equity, DCP Management and Venstar Capital.
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