Arterial Remodeling Technologies has reported positive results of its biodegradable stent from first-in-human Arterial Remodeling Transient DIsmantling Vascular Angioplasty (ARTDIVA) study.
The bioresorbable stent, which promotes positive arterial remodeling, is designed to provide a transient effective scaffold that dismantles and relinquishes its primary mechanical scaffolding function after three months and then bioresorb (disappear) in approximately 18 months.
The 30-patients prospective, first-in-man interventional clinical investigation study is designed to demonstrate the bioresorbable stent for the treatment of patients suffering from a blocked coronary artery and needed a percutaneous coronary intervention.
The primary endpoint of the study includes six months MACE rate, while the secondary endpoint includes the artery lumen evolution over the first 12 months as validated via QCA and OCT.
ARTDIVA study principal investigator and Arterial Remodeling Technologies scientific advisory board member Jean Fajadet said, "I was impressed with the deliverability of the stent, and its good apposition as shown by OCT."
Arterial Remodeling Technologies CEO Machiel van der Leest said the ARTDIVA clinical trial is being conducted at five sites.
"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," Leest added.
CVPath Institute medical director and president Renu Virmani said, "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."