Reva Initiates Enrollment in Trial of the ReZolve2 Bioresorbable Coronary Scaffold

March 28, 2013—Reva Medical, Inc. (San Diego, CA) announced that it has initiated patient enrollment in its clinical trial evaluating its ReZolve2 bioresorbable, sirolimus-eluting coronary scaffold.

According to its press release, Reva will evaluate the safety and performance of ReZolve2 in up to 125 patients at multiple centers in Australia, Brazil, Europe, and New Zealand to provide the data needed to apply for the European CE Mark. The CE Mark allows for commercial sales in Europe and other countries that recognize the mark. The ReZolve2 polymer scaffold is designed to be metabolized and cleared from the body after providing the benefits of a metal drug-eluting stent, the company stated.

Alexandre Abizaid, MD, performed the first patient implantations. Dr. Abizaid is Chief of Coronary Interventions at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil. He served as the Principal Investigator for RESTORE, Reva's previous clinical trial of its ReZolve bioresorbable scaffold, which was initiated in December 2011.

“We were pleased with the outcome of the procedures and saw a noticeable improvement in the deliverability of the ReZolve2 scaffold as compared to the original ReZolve device,” commented Dr. Abizaid in the company's press release. “The improved deliverability, together with the x-ray visibility of the ReZolve2 scaffold, proved to be excellent features of the product. We are excited to be involved in the clinical evaluation of this newest bioresorbable scaffold technology.”

Reva advised that the device does not have regulatory approval and is not commercially available. The company's anticipated commercial product, the ReZolve2 scaffold, is designed to offer full x-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate. In addition, by early encapsulation of the stent in the artery tissue coupled with the loss of scaffold structure over time, the ReZolve2 scaffold may reduce the incidence of late-forming blood clots or otherwise reduce long-term disease progression, potential benefits of bioresorbable scaffolds that have yet to be proven, stated the company.