U.S/French collaboration Arterial Remodeling Technologies (“ART”) says it has achieved a medical milestone with the first-in-human implantation of its biodegradable stent in the “ARTDIVA” (Arterial Remodeling Transient DIsmantling Vascular Angioplasty) clinical trial. ART calls its bioresorbable stent “next-generation”, it being designed to promote positive arterial remodelling and then bioresorb in approximately 18 months. It’s not alone, as offerings of bioresorbable scaffolds from both Abbott and Elixir will testify, although ART reckons its “programmed transitory presence”, whatever that is, sets it apart from the developing crowd.
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 CEO 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.
As previously reported by ART, the company’s analysis of in vivo data confirms that stent dismantling is occurring at around three months, and the overall safety data look encouraging.
Unsurprisingly for anyone in the business, the stent is manufactured using a closely guarded formulation of (poly)lactic acid polymers which are known to be both absorbable in a controlled period and biocompatible, being the building blocks for so many other devices.
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.
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.
Principal investigator for the ART First-In-Man 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. After the case, Dr. Fajadet stated, “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.”
“Investigators are eager to use our next-generation bioresorbable stent because of its key features: it 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.”
“We are very proud of this important milestone in the development of the ART bioresorbable stent,” said Antoine LaFont, M.D., Ph.D., Professor of Medicine, Head Interventional Cardiology Department, Georges Pompidou Hospital (Paris); and, Past Chairman, Interventional Cardiology Working Group, European Society of Cardiology (ESC). Pr. LaFont is a co-founder of ART.
“The ARTDIVA clinical trial is being conducted at five sites,” added Machiel van der Leest, CEO of ART. “Investigators are eager to use our next-generation bioresorbable stent because of its key features: it 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.”
ART’s bioresorbable stent is not approved for investigational use or sale in the U.S.
Source: ART, Business Wire