Safety and Feasibility Data Presented for Amaranth's Fortitude Bioresorbable Scaffold

October 28, 2013—Amaranth Medical (Mountain View, CA) announced the presentation of positive 6-month angiographic results from its first-in-human study of the Fortitude non–drug-eluting bioresorbable scaffold for patients undergoing percutaneous coronary intervention (PCI) with single coronary lesions. The data were presented at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

According to Amaranth Medical, the Fortitude device was successfully delivered in 12 patients within the target lesion. Postdeployment angiographic and intravenous ultrasound (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 6-month angiographic follow-up, and six patients had available independent angiographic analysis indicating 0% binary restenosis.

The company advised that 6-month angiographic follow-up data is available on 10 of the 13 patients enrolled in the first cohort. The results demonstrated 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. IVUS 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.

The Amaranth first-in-human study is a prospective, nonrandomized, 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 6 months and 2 years after implantation.

In the company's announcement, the study's primary investigator Juan F. Granada, MD, commented, “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.” Dr. Granada is Executive Director and Chief Scientific Officer of the Cardiovascular Research Foundation's Jack H. Skirball Center for Cardiovascular Research.