Arterial Remodeling Technologies has reported positive results of its biodegradable stent from the first-in-human arterial remodelling transient dismantling vascular angioplasty (ARTDIVA) study.
The bioresorbable stent, which promotes positive arterial remodelling, is designed to provide a transient effective scaffold which dismantles and relinquishes its primary mechanical scaffolding function after three months and then bioresorbs (disappears) 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 need 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.
Jean Fajadet, ARTDIVA study principal investigator and Arterial Remodeling Technologies scientific advisory board member, said: "I was impressed with the deliverability of the stent, and its good apposition as shown by OCT."
Machiel van der Leest, Arterial Remodeling Technologies CEO, 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 remodelling, and is thus unique among bioresorbable stents on the market and in development," Leest added.
Renu Virmani, CVPath Institute medical director and president, 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."