MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Amaranth Medical, a medical device company developing next-generation bioresorbable scaffolds for the interventional cardiology market, presented nine-month follow-up results from the company’s RENASCENT-II study of the APTITUDE® sirolimus-eluting bioresorbable scaffold (BRS) on Tuesday, May 16th during the Evolving BRS Technology session. In addition, the APTITUDE results will be reviewed during the company’s sponsored symposium: Design Considerations and Clinical Experience of a Novel Thin-Walled High-Performance Bioresorbable Coronary Scaffold, which is scheduled for Wednesday, May 17th. APTITUDE is a poly-L-lactide-based, sirolimus-eluting BRS with a strut thickness of 115-microns. Clinical results from 60 patients enrolled in RENASCENT-II indicate high device success rate (98.3%), scaffold stability as assessed by OCT lumen area maintained at 9 months, high level of strut coverage (97.0%) and low rate of malapposition (0.037%, all covered struts) by OCT at 9 months. Importantly, no instances of thrombosis nor binary restenosis have been reported in these patients.
The company submitted an application for CE Mark for the 115-micron APTITUDE in December 2016, and expects that the CE Mark may be granted in the second half of 2017. Development of a marketing strategy and preparations for commercial launch following allowance of the CE Mark are underway. On the basis of the very positive results from the APTITUDE clinical study, Amaranth plans to begin discussions with potential partners and sources of financing to continue the development of its technology for coronary, peripheral and neurological applications. The company’s near-term efforts also include initial commercial preparations for the world’s first sub-100-micron BRS, MAGNITUDE®, for which the company anticipates a potential market launch in 2018.
Juan F. Granada, executive director and chief innovation officer of the CRF-Skirball Center for Innovation and co-principal investigator of the study, commented, “The BRS field is navigating turbulent waters right now; however, I continue to believe that complete scaffold absorption brings additional value to the patient by decreasing progressive late lumen loss and expanding the re-intervention options in comparison to metallic DES. The technical and clinical performance of the thin-walled APTITUDE BRS has been successfully evaluated in a multi-center clinical trial. I am looking forward to seeing this device used in real-world cases.”
“Clinical outcomes at 9-months for the patients in the RENASCENT-II trial have been excellent, displaying a safety and efficacy profile compared to metallic DES. We hope that long-term data continue to confirm the structural stability and safety of the device and add momentum to the field again,” added Dr. Antonio Colombo, co-principal investigator and director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy.
TCT Presentation Details:
Nine-month clinical and imaging outcomes of a novel ultra-high
molecular weight poly-L-lactide BRS. A prospective multicenter
international investigation: The RENASCENT II
Session: Evolving BRS technology
Chairpersons: E. Edelman, Y. Onuma
May 16, 2017 from 12:00 -1:30 PM in Room 351
Design Considerations and clinical experience of a novel thin-walled
high-performance bioresorbable coronary scaffold
Chairpersons: A. Colombo and G.W. Stone
May 17, 2017 from 4:30-6:00 PM in Room 351
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.