MOUNTAIN VIEW, CA , Oct. 25, 2017 (GLOBE NEWSWIRE) -- Amaranth Medical, a medical device company developing next-generation bioresorbable scaffolds for the interventional cardiology market, will provide an update at the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting on the company’s full line of sirolimus-eluting bioresorbable scaffold (BRS) products during a satellite breakfast meeting and in an oral presentation on October 31, 2017.
New data to be presented at the meeting include nine-month imaging results from 12 of the 70 patients enrolled in the RENASCENT-III study of MAGNITUDE®, the world’s first clinically tested sub-100-micron BRS. Amaranth recently completed enrollment in RENASCENT-III and has commenced plans to submit an application for CE Mark in early 2018.
Amaranth’s TCT presentations will also include previously reported nine-month follow-up results from the 60‑patient RENASCENT-II study of APTITUDE®, a BRS with a strut thickness of 115 microns. Amaranth submitted an application for CE Mark for APTITUDE and is prepared to launch the product in the European market in 2018 pending CE Mark approval.
Juan F. Granada, MD, co-principal investigator of the study, commented, “These presentations will provide an excellent review of the capabilities of Amaranth’s BRS technology, from FORTITUDE®, the company’s first generation BRS, to MAGNITUDE, the thinnest BRS ever tested in clinical trials to date. With its 98-micron strut thickness, MAGNITUDE could represent a significant advance in the space.”
Two-year follow-up safety and efficacy results from the 150‑micron FORTITUDE sirolimus-eluting BRS will also be presented for the first time. These results will provide valuable insight into the long-term safety and biocompatibility of the Amaranth pipeline of products.
The company will also be providing a development update on an 80-micron BRS, which is expected to enter clinical studies in 2018. A scaffold of this strut thickness could potentially rival the characteristics of 80-to-100‑micron drug-eluting metal stents (DES), offering patients a product with all the advantages of a stent without the risks associated with a permanent implant.
Antonio Colombo, MD, director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy and co-principal investigator, added, “I have felt for some time that the next critical improvement in BRS performance will come from a decrease in strut thickness. The 98-micron MAGNITUDE and its 80-micron successor continue to challenge our perceptions of what is possible with bioresorbable technology.”
“We are witnessing an industry that has stalled, with challenges arising in first-generation products and an inability to produce a BRS that matches the strut thickness and performance attributes of today’s metallic stents,” commented Kamal Ramzipoor, CEO of Amaranth Medical. “With our latest generations of BRS, the 115-micron APTITUDE and 98-micron MAGNITUDE featuring metallic stent-like performance, Amaranth believes we have developed products with the desired characteristics to meet industry expectations. We are more committed than ever to advancing this technology with an ultimate goal of making a meaningful impact in the lives of people around the globe.”
Company Presentation Details:
- Satellite breakfast meeting: Welcome to the Future of Bioresorbable Coronary Scaffold Technologies - The Amaranth Medical Thin-Walled BRS Program. October 31st at 6:30am.
- Oral presentation by Dr. Granada: Fortitude, Aptitude, and Magnitude: Progressively Thin-Strut BRS Based on Ultra-High Molecular Weight Amorphous PLLA. October 31st at 4:46pm in the Bioresorbable Vascular Scaffolds, Part 1 - Devices and Emerging Data didactic session
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; and the 98‑micron MAGNITUDE®, which completed patient enrollment in the RENASCENT-III study in 2017. Amaranth’s pipeline also includes an 80‑micron scaffold that is expected to enter clinical studies in 2018. 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.