Initial Clinical Enrollment Completed in Study of Reva's ReZolve Scaffold

July 12, 2012—Reva Medical, Inc. (San Diego, CA) announced that it has completed clinical enrollment with the ReZolve drug-eluting bioresorbable scaffold. A total of 26 patients have been enrolled, and there are no major adverse coronary events (MACE) reported to date. The first patient in the study was enrolled in December 2011. Reva stated that it plans to provide an update on data from these patients at the Transcatheter Cardiovascular Therapeutics 2012 conference, which will be held October 22 through 26 in Miami, Florida.

According to the company's press release, Reva Medical anticipates resumption of clinical trials in the fourth quarter of 2012, when patients will be treated with their lower-profile (6-F guide compatible) ReZolve2 scaffold. ReZolve2 will be evaluated at up to 25 clinical study sites in Brazil, Europe, Australia, and New Zealand. Alexandre Abizaid, MD, who is Chief of Coronary Interventions, Dante Pazzanese Instituto de Cardiologie in Sao Paulo, Brazil, serves as Principal Investigator for the studies of the Reva Medical devices.

As stated in the press release, the ReZolve2 scaffold combines Reva Medical's own stent design with the company's polymer, which is metabolized and cleared from the body. The ReZolve2 scaffold is designed to offer full x-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate. Encapsulation of the stent in the artery tissue coupled with the loss of scaffold structure over time may reduce the incidence of late-forming thrombosis. Reva Medical will require clinical results and regulatory approval before it can begin selling the ReZolve2 scaffold, advised the company.