July 17, 2012 — Arterial Remodeling Technologies (ART) reported that they have achieved a medical milestone with its Arterial Remodeling Transient DIsmantling Vascular Angioplasty (ARTDIVA) clinical trial: The successful first-in-human implantation of its novel biodegradable stent into an 61-year-old male who was suffering from a blocked coronary artery and needed a percutaneous coronary intervention (PCI). ART’s next-generation bioresorbable stent is designed to promote positive arterial remodeling and then bioresorb (i.e., ‘disappear’) in approximately 18 months.
Principal investigator for the ART study is Jean Fajadet, M.D., Co-Director of the Interventional Cardiology Unit, Clinique Pasteur, Toulouse, France; and, a member of ART’s Scientific Advisory Board.
ART’s bioresorbable stent is designed to provide a transient effective scaffold that dismantles and relinquishes its primary mechanical scaffolding function after three months.
ARTDIVA is a 30 patient, prospective, first-in-man interventional clinical investigation in five medical centers to evaluate the ART bioresorbable stent for the treatment of patients with de novo lesions. The primary endpoint is six months major adverse cardiac event (MACE) rate; and the key secondary endpoint is the artery lumen evolution over the first 12 months as validated via qualitative coronary angiography (QCA) and optical coherence tomography (OCT).
For more information: www.art-stent.com