Reva Medical Expands CE Mark Trial for ReZolve2 to Australia and New Zealand

June 27, 2013—Reva Medical, Inc. (San Diego, CA) announced that it has expanded enrollment to multiple clinical sites in Australia and New Zealand for the clinical trial of the company's ReZolve2 bioresorbable scaffold. Earlier this year, the company began enrolling patients at sites in Brazil, Germany, and Poland. Trial enrollment is expected to be completed by the end of September 2013, with up to 30 clinical sites participating and up to 125 patients enrolled. The data will be used to support the company's application for CE Mark approval of the device.

According to Reva, ReZolve2 is a drug-eluting, fully bioresorbable scaffold that is designed to provide all the proven benefits of a permanent metal drug-eluting stent with the advantage of resorbing within the body when it is no longer needed and allowing the artery to return to its natural function.

David Muller, MD, performed the first patient implantation in Australia. Dr. Muller, who is Director of Cardiac Catheterization at St. Vincent's Hospital in Sydney, Australia, serves as Coprincipal Investigator for Reva's CE Mark trial.

“I am very intrigued by the potential clinical benefits that may be realized with the shift from permanent metal stents to temporary scaffolds that dissolve from the body,” commented Dr. Muller in the company's press release. “Reva's device is unique among bioresorbable scaffolds in that it offers ease of inflation and complete scaffold visibility under x-ray. We are excited to play a significant role in evaluating this novel technology in patients.”