PARIS--(BUSINESS WIRE)--Arterial Remodeling Technologies (“ART”) reported today that in vivo data strongly suggest that its next-generation bioresorbable stent promotes positive arterial remodeling in a post-angioplasty porcine model at six months follow-up. In addition, acute safety data are promising: there have been more than 300 MACE-free consecutive implantations of its bioresorbable stent in its preclinical phase of development.
ART’s bioresorbable stent is designed to provide a transient effective scaffold that dismantles and relinquishes its primary mechanical scaffolding function after three months. According to ART’s CEO Machiel van der Leest, who has developed and successfully introduced 15 Class III medical devices during his career, a three-month scaffolding period is commonly recognized by experts as the requisite length of time necessary to allow the healing process to stabilize the artery following trauma generated by angioplasty, and to avoid recoil and constrictive remodeling.
“Our analysis of ART’s in vivo data confirms that stent dismantling is occurring at around three months, and the overall safety data look encouraging thus far,” said Renu Virmani, MD, Medical Director/President, CVPath Institute, Gaithersburg, Maryland. Dr. Virmani also is Clinical Professor, Department of Pathology at Georgetown University, University of Maryland-Baltimore, Uniform University of Health Sciences, and Vanderbilt University.
The Company additionally reported that it has expanded its Scientific Advisory Board with the appointment of interventional cardiologist Murat Tuzcu, MD, PhD, Professor of Medicine, Vice-Chairman, Department of Cardiology, Sydell and Arnold Heart & Vascular Institute; and an Interventional Cardiologist at Cleveland Clinic.
ART’s Scientific Advisory Board also includes:
Jean Fajadet, MD, PhD, Co-Director of Interventional Cardiology at Clinique Pasteur, Toulouse, France; and, President of the European Association of Percutaneous Cardiovascular Interventions (EAPCI);
Antoine Lafont, MD, PhD, Head, Interventional Cardiology Department, Georges Pompidou Hospital (Paris); Past Chairman, Interventional Cardiology Group, European Society of Cardiology (ESC); and,
Professor Michel Vert, one of the world’s leading authorities in polymer chemistry and Former Director of the Research Center for Artificial Biopolymers at France’s National Center for Scientific Research (Centre National de Recherche Scientifique/CNRS).
“The key characteristics of ART’s next-generation bioresorbable stent are that it is made of non-aggressive material, has a programmed transitory presence, and is designed to facilitate natural remodeling,” added Dr. LaFont, who is a co-founder of ART.
Arterial Remodeling Technologies (“ART”) is developing bioresorbable coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. The Company’s technology is based on intellectual property originating from three esteemed institutions: the Cleveland Clinic; the French national research institute, CNRS (Centre National de Recherche Scientifique), Montpellier, France; and, Descartes University, Paris.
CAUTION: ART’s bioresorbable stent is not approved for investigational use or sale in the U.S.