Amaranth Medical Reports Positive Safety and Feasibility Findings for the FORTITUDE® Bioresorbable Scaffold
– Details Presented at Annual Transcatheter Cardiovascular Therapeutics Meeting –
MOUNTAIN VIEW, CA – October 28, 2013 – Amaranth Medical, a privately held medical device company, presented positive six-month angiographic results from its first-in-human study including patients undergoing percutaneous coronary intervention (PCI) with single coronary lesions. The FORTITUDE® non-drug eluting bioresorbable scaffold was successfully delivered in 12 patients within the target lesion. Post-deployment angiographic and IVUS analysis indicated that the FORTITUDE scaffold maintained its mechanical integrity, showing no indication of vessel recoil or other structural failures. At the time of the presentation, 10 patients had completed six-month angiographic follow up and six patients had available independent angiographic analysis indicating 0% binary restenosis. The data was presented at the “Next generation DES and bioabsorbable scaffolds” session at the Transcatheter Cardiovascular Therapeutics (TCT) meeting on October 27, 2013 in San Francisco, CA.
“Short-term failure of bioresorbable stents is often a result of a device’s inability to withstand the biomechanical challenges imposed by the atherosclerotic plaque resulting in recoil and restenosis. The FORTITUDE scaffold has shown high mechanical strength and significant durability during the first six months, which is key to successful vessel remodeling,” said Kamal Ramzipoor, the general manager and chief technical officer of Amaranth. “Importantly, the proprietary materials that provide FORTITUDE’s mechanical integrity also allow it to be entirely bioresorbable, thus potentially restoring vascular physiology reducing the risk of late stent thrombosis and improving long-term clinical outcomes.”
Six-month angiographic follow-up data is available on 10 of the 13 patients enrolled in the first cohort and demonstrate excellent biomechanics and biocompatibility of the scaffolds. An independent core laboratory has reviewed findings on the first six patients, and affirmed that late lumen loss is similar to that observed with bare metal stents. Intravascular ultrasound and optical coherent tomography (OCT) images indicate that the scaffolds are fully opposed to the vessel walls with no indication of recoil or other compromise to their mechanical integrity.
Juan F. Granada, M.D., executive director and chief scientific officer of the Cardiovascular Research Foundation (CRF) Skirball Research Center and primary investigator of the Amaranth first-in-human study, added, “The rapid evolution of this field has been hampered by the inability to develop thin-strut vascular scaffolds displaying stable long-term biomechanical behavior. This early human experience confirms both the positive biocompatibility profile of the polymer and biomechanical properties of this device in the absence of drug elution. From our experience to date, we are optimistic that the next generation of the FORTITUDE technology will permit further miniaturization of the strut but still provide the necessary balance between mechanical strength and bioresorption.”
About the First-in-Human Study
The Amaranth first-in-human study is a prospective, non-randomized, investigational study to assess the safety and feasibility of the FORTITUDE bioresorbable scaffold. The study is enrolling patients with symptomatic coronary artery disease in two cohorts, the first of which completed enrollment in mid 2013. Patients who will be enrolled in the second cohort will receive Amaranth’s second generation bioresorbable scaffold which possesses drug-eluting capabilities. This second cohort will begin enrolling in the first half of 2014. Angiographic and OCT follow-up will be conducted on all study participants at six months and two years following implantation.
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 DCP Management, Charter Life Sciences, Bio*One Capital, Philip Private Equity and Venstar Capital.
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