Volume 92, Issue 3 pp. E246-E253
Coronary Artery Disease (E-only Articles)

First in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous PLLA bioresorbable scaffold in the absence of anti-proliferative drugs: Two-year imaging results in humans

Miguel Moncada MD

Miguel Moncada MD

EMMSA Clínica Especializada, Bello, Colombia

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Juan A. Delgado MD

Juan A. Delgado MD

San Vicente Fundacion and Hospital Manuel Uribe Angel, Medellin, Colombia

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Antonio Colombo MD

Antonio Colombo MD

San Raffaele Scientific Institute, Milan, Italy

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Pawel Gasior MD, PhD

Pawel Gasior MD, PhD

3rd Department of Cardiology, Medical University of Silesia, Katowice, Poland

CRF-Skirball Center for Innovation, New York, New York

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Kamal Ramzipoor BS, ME

Kamal Ramzipoor BS, ME

Amaranth Medical, Inc, Mountain View, California

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Alex Estrada BS, ME

Alex Estrada BS, ME

Amaranth Medical, Inc, Mountain View, California

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Chang Lee BS, MS, ME

Chang Lee BS, MS, ME

Amaranth Medical, Inc, Mountain View, California

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Danny Dokko BS, MS

Danny Dokko BS, MS

Amaranth Medical, Inc, Mountain View, California

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Juan F. Granada MD

Corresponding Author

Juan F. Granada MD

CRF-Skirball Center for Innovation, New York, New York

Correspondence Juan F. Granada, MD, CRF - Skirball Center for Innovation, Cardiovascular Research Foundation, 8 Corporate Dr., Orangeburg, NY, 10965. Email: [email protected]Search for more papers by this author
First published: 15 December 2017
Citations: 8

Funding information: This study was funded by Amaranth Medical, Inc.; Mountain View, CA.

Abstract

Objectives

In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA bioresorbable scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques.

Background

The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs.

Methods

A total of 10 patients undergoing single scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years.

Results

At 6 months, mean intra-scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases.

Conclusion

At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.

CONFLICT OF INTEREST

By the time the study was performed the authors Ramzipoor K, Estrada EA, Dokko D and Lee C were full time employees of Amaranth Medical, Inc; Mountain View, CA. Granada JF is a scientific advisor of Amaranth Medical, Inc. The authors Moncada M, Delgado JA, Colombo A and Gasior P do not have any conflict of interest.

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