REVA Medical recruiting in A/NZ for stent trial
REVA Medical (ASX:RVA) has started enrolling patients in Australia and New Zealand for its clinical trial of ReZolve 2, its drug-eluting bioresorbable cardiac scaffold.
The trial is being led by Dr David Muller, Director of Cardiac Catheterization at St Vincent’s Hospital in Sydney, who has conducted the first Australian patient implant of the scaffold.
The trial aims to provide the data necessary to apply for European CE Mark approval. REVA Medical started recruiting patients in Brazil, Germany and Poland earlier this year.
The company aims to involve up to 125 patients across up to 30 clinical sites. Enrolment is scheduled for completion by the end of September.
“I am very intrigued by the potential clinical benefits that may be realised with the shift from permanent metal stents to temporary scaffolds that dissolve from the body,” Dr Muller said.
ReZolve 2 is the successor and commercial candidate for ReZolve, a bioresorbable scaffold that has shown promise in clinical trials.
In May, REVA Medical appointed Michel Vanbrabant as managing director to help guide the company through its planned European market launch.
REVA Medical shares were trading unchanged at $0.56 as of around 1.30 pm on Monday.
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