Reva Medical, a US-based medical device company, has started enrolling patients with its ReZolve2 bioresorbable scaffold at multiple clinical sites in Australia and New Zealand.
This is an addition to the previously announced sites in Brazil, Germany and Poland, which began enrolling patients in the early 2013.
About 125 patients are expected to enroll in the company’s clinical trials to provide with the necessary data to apply for CE Mark in Europe.
Rezolve2 is a drug-eluting fully bioresorbable scaffold which is intended to provide permanent metal drug-eluting stent benefits.
In Australia, the first patient implant has been performed by Dr. David Muller.
Sydney’s St. Vincent’s Hospital Cardiac Catheterization director and Reva CE trial co-principal investigator Dr. David Muller said that he is 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.
"REVA’s device is unique among bioresorbable scaffolds in that it offers ease of inflation and complete scaffold visibility under x-ray," Muller added.
Enrollment is expected to be completed by the end of September 2013 with participation from about 30 clinical sites.