Amaranth Medical, a privately held medical device company, announced that a presentation of the 9-month clinical and imaging results from the company’s FORTITUDE® sirolimus-eluting bioresorbable scaffold (BRS) took place during the First Report Investigations session at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium on Monday, October 31st. Dr. Antonio Colombo, co-principal investigator and director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy presented the main clinical and imaging findings from the 62 patients who received the FORTITUDE scaffold.
“This study represents an important milestone for this technology, as it demonstrates not only the feasibility of delivery but the mechanical stability of the device over time,” commented Juan F. Granada, executive director and chief innovation officer of the CRF-Skirball Center for Innovation and co-principal investigator of the study. “The very low presence of scaffold discontinuities (1-case, 1.7%) present within healthy neointima seen in the OCT analysis is very encouraging and supports not only the biomechanical stability of the device but also confirms the potential for future miniaturization of the strut thickness.”
Dr. Colombo added, “A scaffold such as FORTITUDE that is fully bioresorbable with comparably high radial strength to a metal stent is quite exciting. Yet more exciting is the potential of Amaranth’s pipeline to deliver equally durable thinner-strut BRS with the profile of metallic drug eluting stents. The introduction of thinner-strut BRS would allow us to treat more complex lesions and deliver the promise of full device absorption to a greater number of patients.”
TCT Presentation Details:
FORTITUDE: Nine-Month Clinical, Angiographic, and OCT Results with an Amorphous PLLA-Based Sirolimus-Eluting Bioresorbable Vascular Scaffold in Patients with Coronary Artery Disease
Main Arena II in the Walter E. Washington Convention Center in Washington, DC
Plenary Session VI. First Report Investigations 2
Monday, October 31, 2016 from 12:00 pm – 1:00 pm ET
In addition to FORTITUDE, Amaranth has developed the thinner-strut APTITUDE™ 115-micron sirolimus-eluting BRS. APTITUDE is being tested in the RENASCENT-II study, which completed enrollment in May 2016. Short-term results showed the device to be highly deliverable in more complex anatomies, while retaining a high radial strength. In the patients who have completed their nine-month imaging follow-up, the APTITUDE scaffold continues to show comparable clinical results and mechanical stability compared to the validated FORTITUDE scaffold. The company anticipates initiating an application for a CE Mark this quarter for APTITUDE, with an expectation that the CE Mark could be granted by the end of 2017.
Dr. Granada added, “The market will favor bioresorbable scaffolds but only if they are as deliverable, mechanically durable and clinically safe as are metallic drug eluting stents. Amaranth’s thinner-strut scaffolds have the potential to achieve that goal and change the way we treat patients today.”
“We are confident that our results to date support CE Mark, and we look forward to working with regulators to bring APTITUDE to market,” added Kamal Ramzipoor, president and CEO of Amaranth. “We have begun forming our commercial strategy and believe that we have the required infrastructural capabilities to launch our product and reach the appropriate interventional cardiology market. We will provide more details about these plans as we move forward in the regulatory process.”
The Cardiovascular Research Foundation (CRF) is an independent, academically focused, nonprofit organization dedicated to helping doctors improve the survival and quality of life of people suffering from heart and vascular disease through research and education. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of CRF, is the world’s premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit www.crf.org and www.tctconference.com.
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. 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.
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