French startup Arterial Remodeling Technologies [3] (ART) has reported achieving a clinical-trial milestone with the successful first-in-human implantation of its biodegradable stent. The device was implanted into a 61-year-old man suffering from a blocked coronary artery and requiring a percutaneous coronary intervention. He is the first patient enrolled in the ARTDIVA (Arterial Remodeling Transient Dismantling Vascular Angioplasty) clinical trial, which is being conducted at five medical centres, notes a press release [4] published on 16 July.
ART's next-generation bioresorbable stent is designed to promote positive arterial remodelling and completely resorb in approximately 18 months. The three-month resorption rate is a key feature of the stent. According to CEO Machiel van der Leest, a three-month scaffolding period is commonly recognised by experts as the length of time necessary to allow the healing process to stabilise the artery following trauma generated by angioplasty, and to avoid recoil and constrictive remodelling.
Jean Fajadet, MD, Co-Director of the Interventional Cardiology Unit, Clinique Pasteur, in Toulouse, France, and a member of ART's scientific advisory board, was 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 [optical coherence tomography]." Fajadet is Principal Investigator for the ART First-In-Man study.
The device's programmed transitory presence that facilitates natural remodelling is a unique feature among bioresorbable stents on the market and in development, according to van der Leest. He has developed and successfully introduced 15 Class III medical devices during his career.