Arterial Remodeling Technologies has gained CE Mark approval for its next generation drug free, pure bioresorbable scaffold used to treat coronary artery disease.
ART’s advanced bioresorbable scaffold is designed to provide a transient effective scaffolding that dismantles and relinquishes its primary mechanical function after three months, a commonly recognised requisite length of time necessary to allow the healing process to stabilise 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 is particularly suitable for the treatment of larger lumen coronary artery lesions.
The CE Mark was achieved following the completion of extensive pre-clinical research, including up to three-years of follow-up, and supportive clinical results from leading coronary angioplasty centres such as the Hôpital Européen Georges Pompidou in Paris and investigators such as Dr Jean Fajadet at the Clinique Pasteur in Toulouse.
In March, the rights to ART’s coronary drug eluting bioresorbable scaffold technology were acquired by Terumo which will utilise the pure bioresorbable scaffold as the platform for its next generation of coronary drug eluter.
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.
“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,” stated Machiel van der Leest, CEO of ART. “We are very pleased with the clinical performance of the pure bioresorbable scaffold.”
Source: Business Wire