Early Clinical Results Presented for Reva's ReZolve2 Bioresorbable Scaffold

October 28, 2013—Reva Medical, Inc. (San Diego, CA) announced that initial results from the clinical investigation of patients treated with the company's ReZolve2 sirolimus-eluting bioresorbable coronary scaffold were presented at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California. Ricardo Costa, MD, from the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, a leading enrollment center for the trial, reported the data.

"I am pleased to report that in the first 65 patients treated with ReZolve2 who have completed 30-day follow-up, there have been no reported major adverse coronary events, with no incidences of ischemic target revascularization, myocardial infarction, or stent thrombosis,” Dr. Costa commented in the company's announcement. “In this preliminary analysis, the scaffold is performing well and investigators in the trial continue to appreciate the complete visibility of ReZolve2 as well as the ability to expand the scaffold to the desired implant size with a single inflation."

Reva's ReZolve2 trial (RESTORE II) began patient enrollment in March 2013 and it will enroll up to 125 patients at multiple centers in Australia, Brazil, Europe, and New Zealand. The trial will provide the data for the company's application for European CE Mark approval. The 30-day data on the remaining patients enrolled in the trial, as well as longer-term data, will be presented in May at the EuroPCR 2014: Paris Course on Revascularization in Paris, France, according to the company.

On October 29 at the TCT 2013 conference, Dr. Costa will present 12-month data on patients enrolled in the RESTORE clinical trial, which is a pilot study evaluating the safety and performance of the first-generation ReZolve sirolimus-eluting bioresorbable coronary scaffold.

According to the company, the ReZolve2 scaffold is designed to offer full x-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate. Reva stated that the ReZolve2 scaffold may reduce the incidence of late-forming blood clots or otherwise reduce long-term disease progression by early encapsulation of the stent in the artery tissue coupled with the loss of scaffold structure over time. These potential benefits of bioresorbable scaffolds have yet to be proven and the company requires clinical results and regulatory approval for the device.

Reva's ReZolve product family is in the clinical-study phase. The company expects the ReZolve2 to be its initial commercial product. Reva's pipeline of products include new and thinner bioresorbable scaffolds for coronary and peripheral applications that include the company's stent design and polymer that is metabolized and cleared from the body, as well as the x-ray visibility and other features of the ReZolve platform.