Reva Completes Enrollment in ReZolve2 Clinical Trial

January 13, 2014—Reva Medical, Inc. (San Diego, CA) announced that it has completed enrollment in the RESTORE II clinical trial of the ReZolve2 drug-eluting bioresorbable scaffold. A total of 112 patients have been enrolled in the trial to provide the data needed to apply for European CE Mark approval. The company anticipates that it will file the CE Mark application before the end of 2014.

The company stated that patient enrollment was conducted at clinical sites on three continents. The company will provide an update on data from these patients at the EuroPCR: Paris Course on Revascularization, which will be held in May 2014 in Paris, France.

Reva is a development-stage medical device company focused on the development and eventual commercialization of its proprietary bioresorbable stent products. The ReZolve product family, which is in a clinical study phase, combines Reva's proprietary stent design with a proprietary polymer that is metabolized and cleared from the body.

The ReZolve2 scaffold, which is Reva's anticipated initial commercial product, is designed to offer full x-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate.

The company stated that 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. Reva will require clinical results and regulatory approval before it can begin selling the ReZolve2 scaffold, advised the company.