REVA Announces First Clinical Results From ReZolve2 Trial
REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") announced initial clinical results from patients treated with its ReZolve2 sirolimus-eluting bioresorbable coronary scaffold at Transcatheter Therapeutics 2013 ("TCT"), the world's leading interventional cardiology conference, which is being held this week in San Francisco, California. The ReZolve2 trial is currently enrolling up to 125 patients at multiple centers in Australia, Brazil, Europe, and New Zealand to provide the data needed to apply for European CE Marking. Patient enrollment was initiated in March 2013 and is currently ongoing.
Reporting on the results was Dr. Ricardo Costa from the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, a leading enrollment center for the trial. "I am pleased to report that in the first 65 patients treated with ReZolve2 who have completed 30-day follow-up, there has been no reported Major Adverse Coronary Events (MACE), with no incidences of ischemic target revascularization (TLR), myocardial infarction (heart attack), or stent thrombosis. 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." Dr. Costa also spoke about REVA's pipeline products. These include new and thinner bioresorbable scaffolds for coronary and peripheral applications that feature the x-ray visibility and distinctive product features of the ReZolve platform.
"These early results in patients treated with ReZolve2 represent an important step toward CE Marking and eventual commercialization of REVA's first commercial product," commented REVA's CEO, Bob Stockman.
"We look forward to presenting 30-day data on the remaining patients enrolled in the trial as well as longer-term data at the Paris Course on Revascularization ("EuroPCR"), which will be held next May in Paris, France."
The presentation materials delivered at the conference are posted under the Investor Relations section of REVA's website at www.revamedical.com
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(R) sirolimus-eluting bioresorbable coronary scaffold, during TCT's bioresorbable oral abstract session on Tuesday, October 29, 2013 PDT.