News | October 07, 2014

Amaranth Starts Clinical Trial of Fortitude

Amaranth Medical initiates clinical trial of the second-generation Fortitude Bioresorbable Drug-Eluting Scaffold

October 7,2014 — Amaranth Medical announced patient enrollment in multiple centers in Colombia, South America in MEND-II, a clinical trial to assess safety and feasibility of the company's Fortitude Sirolimus-Eluting Bioresorbable Scaffold in patients with symptomatic coronary artery disease. As seen with the first generation scaffold, preliminary patient results using optical coherence tomography (OCT) following implantation show that the scaffolds were fully apposed to the vessel wall achieving optimal acute lumen gain. Additional details of Amaranth's bioresorbable scaffold program will be presented at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) Meeting during the didactic symposium.

"The Fortitude Sirolimus-Eluting Bioresorbable Scaffold is designed to have comparable mechanical strength and durability to our bare bioresorbable scaffold, while also providing the controlled release of sirolimus to reduce the risk of restenosis," said Kamal Ramzipoor, chief executive officer of Amaranth. "We look forward to advancing Fortitude through this clinical trial and initiating a study next year in Europe, both of which will support our planned application for CE Mark."

Complete 12-month clinical follow-up results on the 13 patients enrolled in MEND-I, Amaranth's clinical study of the bare Fortitude, will also be presented in the aforementioned didactic symposium at TCT. All patients enrolled in MEND-I have completed their one-year follow-up visits. This study met its primary endpoint of six-month incidence of target vessel failure with no incidents of stent thrombosis or mechanical failure. Importantly, late lumen loss, as confirmed by an independent core lab, was shown to be comparable to that of bare metal stents.

Juan F. Granada, M.D., executive director and chief innovation officer of the CRF-Skirball Center for Innovation (SCI) and primary investigator of the Amaranth clinical program said " while the Fortitude Sirolimus-Eluting Bioresorbable Scaffold is still in early stages of enrollment, it appears to have similar mechanical behavior but enhanced deliverability compared to the first-generation bare scaffold."

For more information visit: www.amaranthmedical.com

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
News | Cardiac Diagnostics| September 12, 2017
Contracting shingles, a reactivation of the chickenpox virus, increases a person’s risk of stroke and heart attack,...
Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study in Denmark

Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study. Photo credit: Lisbeth Hasager Justesen, Viborg Hospital.

News | Cardiac Diagnostics| September 12, 2017
September 12, 2017 — A new screening program for vascular disease saves one life for every 169 men assessed, accordin
Overlay Init