ART's Bioresorbable Scaffold Receives CE Mark Clearance

May 18, 2015—Arterial Remodeling Technologies (ART) has announced European CE Mark clearance for its next-generation, drug-free, pure bioresorbable scaffold for the treatment of coronary artery disease. The CE Mark was achieved after the completion of extensive preclinical investigation, including up to 3 years of follow-up and supportive clinical results from leading coronary angioplasty centers.

According to the company, the ART bioresorbable device is designed to provide a transient, effective scaffolding that dismantles and relinquishes its primary mechanical function after 3 months. The design allows complete resorption of the polymer within 24 months. The device is particularly suitable for the treatment of larger-lumen coronary artery lesions, stated the company.

ART advised that Terumo Interventional Systems acquired exclusive acquisition rights for the coronary drug-eluting bioresorbable scaffold technology through an agreement concluded between the companies in March 2014. The ART scaffold will serve as the platform for the next generation of coronary drug-eluting bioresorbable scaffolds to be developed by Terumo. 

Other indications, including the peripheral vascular application of the pure and drug-eluting scaffolds, are being developed by Vascular Bioresorbable Technologies through an exclusive license agreement to further develop ART’s platform technology.