November 7, 2011 – Arterial Remodeling Technologies (ART) reported that in vivo data strongly suggest that its second-generation bioresorbable stent promotes positive arterial remodeling in a post-angioplasty porcine model at three months follow-up. In addition, acute safety data are excellent: there have been more than 250 MACE-free consecutive implantations of its bioresorbable stent in its preclinical phase of development.
ART also reported that it has appointed interventional cardiologist Jean Fajadet, M.D., to its scientific advisory board. Fajadet is co-director of interventional cardiology at Clinique Pasteur, Toulouse, France, and president of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).
“We are extremely pleased to have Dr. Fajadet, a key international opinion leader in interventional cardiology, join ART’s scientific advisory board,” said Machiel van der Leest, CEO. “Dr. Fajadet will play a critical role as we move toward our First-in-Human milestone with our second-generation bioresorbable stent.”\
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 van der Leest, who has developed and successfully introduced 15 Class III medical devices during his career, this 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 the trauma generated by angioplasty, and to avoid recoil and constrictive remodeling. Extensive in vivo data demonstrate that ART’s polymer is designed to be safe while triggering only a minimal inflammatory response that is typical for biocompatible resorption processes.
“The key characteristics of ART’s second-generation bioresorbable stent are that it is made of non-aggressive material, has a programmed transitory presence, and — most important — facilitates natural remodeling,” said Antoine LaFont, M.D., Ph.D., professor of medicine, head of the Interventional Cardiology Department, Georges Pompidou Hospital (Paris), and past chairman, Interventional Cardiology Working Group, European Society of Cardiology (ESC). LaFont is a co-founder of ART.
ART’s novel biopolymers have been developed in conjunction with one of the world’s leading authorities in bioresorbable polymers, research professor Michel Vert, Ph.D., who is former director of the Research Center for Artificial Biopolymers at France’s National Center for Scientific Research (Centre National de Recherche Scientifique/CNRS). Vert is a co-founder of ART.
For more information: www.art-stent.com