13 Sep 2012, BioSpectrum Bureau , BioSpectrum
Singapore: REVA Medical, listed with the ASX, has appointed Dr David Muller, director, Cardiac Catheterization at St Vincent's Hospital, Sydney, Australia, as co-principal investigator for the company's upcoming RESTORE II clinical trial. Patient enrollment for the trial is expected to begin in the first quarter of 2013.
REVA Medical develops minimally invasive medical devices that leverage its proprietary biomaterial and stent technologies to improve treatment of coronary artery disease.
Dr Alexandre Abizaid of Dante Pazzanese Institute of Cardiology, who successfully led REVA's initial RESTORE pilot study, will continue as a co-principal investigator with Dr Muller for the RESTORE II trial. Dr Muller is a renowned interventional cardiologist and leads the stenting efforts at one of Australia's largest and most prestigious centers.
"I am most pleased to join an excellent group of physician colleagues to evaluate the performance of REVA's unique ReZolve2 drug-eluting bioresorbable scaffold," said Dr Muller. "I am honored to join Dr Abizaid as Co-PI in overseeing REVA's expanding trial efforts in numerous countries around the world."
Chairman and CEO Robert Stockman said, "We are so pleased to add Dr Muller to the roster of exceptional clinicians who have helped us pioneer the development of our unique product. We have looked forward to Australia's participation as a leading center of clinical trial excellence for REVA and with Dr. Muller at Australia's helm we couldn't be in better hands."
The RESTORE II trial is a multicenter safety and performance study of REVA's ReZolve2 sirolimus-eluting bioresorbable coronary scaffold that will enroll 125 patients at up to 30 clinical centers in Australia, Austria, Brazil, Germany, New Zealand and Poland. Data gathered from the RESTORE II trial will be used as the basis to support CE mark application of the ReZolve2 scaffold.