01 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Australia-based Reva Medical has initiated enrolment of patients for its ReZolve 2 bioresorbable scaffold at multiple clinical sites in Australia and New Zealand. This is in addition to previously announced sites in Brazil, Germany and Poland, which began enrolling patients earlier this year. Up to 125 patients are expected to be enrolled in REVA's clinical trial to provide the data necessary to apply for European CE Marking.
ReZolve2 is a drug-eluting fully bioresorbable scaffold designed to provide all the proven benefits of a permanent metal drug-eluting stent, with the advantage of resorbing from the body when it is no longer needed and allowing the artery to return to its natural function.
The first patient implant in Australia was performed by Dr David Muller, director of Cardiac Catheterization at St Vincent's Hospital in Sydney, and the co-principal investigator for Reva's CE trial.
"I am very intrigued by the potential clinical benefits that may be realized with the shift from permanent metal stents to temporary scaffolds that dissolve from the body," commented Dr Muller. "Reva's device is unique among bioresorbable scaffolds in that it offers ease of inflation and complete scaffold visibility under x-ray. We are excited to play a significant role in evaluating this novel technology in patients."
Enrollment in Reva's CE trial is expected to be complete by the end of September 2013, with up to 30 clinical sites participating.