Arterial Remodeling Technologies (ART) has reported the successful first-in-human implantation of its novel biodegradable stent. The case is part of the ARTDIVA (Arterial remodeling transient dismantling vascular angioplasty) clinical trial.
ART’s next-generation bioresorbable stent is designed to promote positive arterial remodeling and then bioresorb in approximately 18 months.
Principal investigator for the ARTDIVA study is Jean Fajadet, co-director of the Interventional Cardiology Unit, Clinique Pasteur, Toulouse, France; and, a member of ART’s Scientific Advisory Board. Fajadet commented: “I am pleased with the first human use of the ART stent. I was impressed with the deliverability of the stent, and its good apposition as shown by OCT.”
“Our next-generation bioresorbable stent is made of non-aggressive material and is designed to have a programmed transitory presence in order to facilitate natural remodeling, and is thus unique among bioresorbable stents on the market and in development,” said Machiel van der Leest, CEO of ART.
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, a three-month scaffolding period is commonly recognised by experts as the requisite length of time necessary to allow the healing process to stabilise the artery following trauma generated by angioplasty, and to avoid recoil and constrictive remodeling.
ARTDIVA is a 30 patient, prospective, first-in-man interventional clinical investigation in five medical centres to evaluate the ART bioresorbable stent for the treatment of patients with de novo lesions. The primary endpoint is six months MACE rate; and the key secondary endpoint is the artery lumen evolution over the first 12 months as validated via QCA and OCT.
ART’s bioresorbable stent is not approved for investigational use or sale in the USA.