European Regulators OK Bioresorbable Scaffold From Arterial Remodeling Technologies

Privately held Arterial Remodeling Technologies (ART) has received CE Mark clearance for its next-generation drug free, pure bioresorbable scaffold used to treat coronary artery disease.

The company completed “extensive” pre-clinical research in support of its product development application, including up to three-years of follow-up, and positive clinical results from coronary angioplasty centers such as the Hôpital Européen Georges Pompidou in Paris, France, and investigators like Jean Fajadet, M.D., at the Clinique Pasteur in Toulouse, France.

ART’s bioresorbable scaffold is designed to provide a transient effective scaffolding that dismantles and relinquishes its primary mechanical function after three months — enough time to heal and stabilize the artery. In addition, the scaffold is designed to allow complete resorption of the polymer within 24 months. ART’s drug-free, pure bioresorbable scaffold particularly is suitable for the treatment of larger lumen coronary artery lesions, bigwigs noted.

“Receiving the CE Mark for our pure bioresorbable scaffold is a significant milestone for ART as we continue to develop this technology for the treatment of coronary artery and peripheral vascular disease,” CEO Machiel van der Leest said in a news release. “We are very pleased with the clinical performance of the pure bioresorbable scaffold.”

Through an agreement reached in March 2014, Terumo acquired exclusive acquisition rights for the coronary drug eluting bioresorbable scaffold technology. The pure bioresorbable CE Marked scaffold developed by ART will serve as the platform for the next generation of coronary drug eluting bioresorbable scaffolds to be developed by Terumo. Coronary artery disease is the most common type of heart disease and a leading cause of death among men and women, according to industry data.

Vascular Bioresorbable Technologies also has licensed ART’s platform technology to develop a peripheral vascular application of the pure and drug-eluting scaffolds.

Based in Paris, Arterial Remodeling Technologies is developing bioresorbable polymer scaffolds that promote the natural remodeling of an injured artery. The company’s technology is based on intellectual property originating from three institutions: Cleveland Clinic; French national research institute (CNRS); and Descartes University in Paris. Its investors include Bpifrance, Idinvest Partners, Turenne Capital Partners, Matignon Investissement et Gestion, Vesale Partners and Amundi Asset Management.