Mountain View, CA, May 18, 2015 (GLOBE NEWSWIRE) -- Amaranth Medical, a privately held medical device company, announced plans to report clinical results from the Company's ongoing trial of its second-generation FORTITUDE sirolimus-eluting bioresorbable scaffold (BRS) at the upcoming EuroPCR 2015. Dr. Juan F. Granada, executive director and chief innovation officer of the CRF-Skirball Center for Innovation (SCI) will present these updates on May 21, 2015 during the Novel Bioresorbable Scaffold Technology for the Future session.
The FORTITUDE sirolimus-eluting BRS is being evaluated in two multi-center, international trials, both of which are designed to support a planned application for CE Mark. In this clinical program, a total 49 patients have been treated in centers in Colombia, South America (MEND-II trial) and Italy (RENASCENT trial). Early preliminary results from these studies demonstrate the scaffold's capabilities to navigate through complex anatomies with a balance of deliverability and biomechanical performance. No peri-procedural complications have been reported to date.
"Our clinical trial experience with the FORTITUDE BRS is very encouraging," commented Dr. Granada, primary investigator of the MEND-II study. "Building upon its high biocompatibility profile, the FORTITUDE BRS exhibits the biomechanical behavior expected by the interventional community in addition to the long-term vascular benefits of device absorption, both of which have significant impact on clinical outcomes. Specifically, the FORTITUDE BRS has the capability to over-expand approximately four-fold what is possible with commercially available BRS, providing physicians with the operational flexibility we have with metallic scaffolds."
Dr. Antonio Colombo, Director of the Cardiac Cath Lab and Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus in Milan, Italy, and primary investigator of the RENASCENT trial, added, "While results from the RENASCENT study are still early, we are encouraged by the acute performance of the device, which shows no indication of device failure or peri-procedural complications, further supporting the mechanical strength and durability of the device platform. I look forward to enrolling additional patients and completing nine‑month imaging follow-up visits, which will unveil the real potential of this second-generation BRS platform."
Additional details of Amaranth's technology clinical program will be provided by Dr. Granada in a presentation titled: "Bench Testing and Pre-Clinical Evaluation of the Amaranth PLLA Scaffold," which takes place at 11:15am on Thursday May 21, 2015 during the session: Novel Bioresorbable Scaffold Technology for the Future.
"The Amaranth BRS incorporates an innovative polymer technology that results in enhanced biocompatibility and biomechanical properties compared to other bioresorbable scaffolds. Indeed, we believe that we are the only company in the industry that has succeeded in achieving both long-term safety and "late gain" in a bioresorbable polymeric scaffold without the use of antiproliferative drugs," noted Kamal Ramzipoor, Amaranth's chief executive officer. "Moreover, the FORTITUDE scaffolds have generated acute and long-term clinical data that confirm their radial strength, biomechanical stability and high retention forces. We believe that these characteristics offer meaningful differentiation relative to currently available products."
The MEND-II and RENASCENT trials are built upon the successful results from the first-in-human clinical study of Amaranth's bare FORTITUDE BRS, MEND-I, which was conducted in Colombia, South America. This study met its primary endpoint at six months. Patients who had been enrolled in MEND-I continue to show excellent clinical performance two years after implant. Further, angiographic and OCT follow-up demonstrate late lumen gain in treated vessels at two years, relative to six months.
About the FORTITUDE Studies
The Amaranth MEND-II and RENASCENT studies are ongoing prospective, non-randomized, investigational studies to assess the safety and feasibility of the FORTITUDE drug-eluting bioresorbable scaffold (BRS). MEND-II enrolls patients in multiple centers in Colombia who have symptomatic coronary artery disease, while RENASCENT enrolls patients with similar characteristics in several Italian centers. Following implantation, participants in MEND-II and RENASCENT will be evaluated at nine and 24 months and five years. Amaranth plans to submit an application for CE Mark on the basis of data generated in the MEND-II and RENASCENT clinical program.
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 lead product is the FORTITUDE® scaffold, which is 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.