ReZolve is a fully bioresorbable polymer scaffold which will have all the advantages of a metal drug-eluting stent, with the benefit of dissolving from the body after it is no longer needed.
The prospective multi-centre RESTORE study will demonstrate the safety and performance of ReZolve in 50 patients with symptomatic coronary artery disease due to one or more discrete areas of blockage.
The primary endpoint of the study includes freedom from symptomatic target lesion revascularization at a six-month clinical evaluation, and imaging of the stented area at 12 months.
Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil Coronary Interventions chief Alexandre Abizaid said the procedure went very smoothly in a 90% occluded coronary artery utilizing standard practices that are used to implant conventional metallic stents.
Reva chairman and CEO Bob Stockman said Reva now joins other companies who have advanced the treatment of coronary artery disease, and will evaluate the novel and highly anticipated technology.
Reva intends to commence a larger scale clinical trial to support for CE Mark approval in Europe.
