REVA Medical stent trial shows positive results

Medical device company REVA Medical (ASX:RVA) has presented encouraging early results from a safety trial of its ReZolve coronary scaffold to treat coronary artery disease.

The results, presented at the European Course on Revascularization in Paris, show that the 16 patients enrolled in the RESTORE pilot trial have suffered no major adverse coronary events.

There were no recorded incidences of heart attack, stent thrombosis or target lesion revascularisation among the coronary artery disease patients.

Coronary stents are tube-like devices designed to encourage the restoration of diseased arteries. They are implanted after an angioplasty during coronary artery disease treatment.

ReZolve is a scaffold consisting of a drug-eluting coronary stent that, unlike traditional metal stents, is made of a proprietary polycarbonate polymer. The material is bioresorbable, so it dissolves over time once the healing of an artery occurs.

Bioresorbable stents have the potential to reduce the complications associated with the use of permanent metal stents, including potentially fatal blood clotting.

The first patient involved in the RESTORE trial was implanted with the scaffold in December. The company plans to continue to enrol patients in the pilot trial through to the second quarter, but will conclude enrolment no later than June 30.

The first cohort of patients will be evaluated on a six month follow-up, and the results from this evaluation will be provided at October's Transcatheter Therapeutics Conference.

The patients involved in this study were implanted with the first-generation version of the ReZolve stent. But REVA Medical has developed a thinner version of the product, named ReZolve2, that no longer needs protective sheath.

According to REVA Medical CEO Bob Stockman, ReZolve2 has shown significantly improved delivery performance in animal trials. “ReZolve2 will be the product we [will] commercialise,” he said.

“We believe that by improving deliverability we will significantly speed up the rate of patient enrolment in our upcoming CE trial.”

REVA Medical is incorporated in Delaware in the US, but is listed exclusively on the ASX. REVA Medical (ASX:RVA) shares were trading 5% higher at $0.630 by around 2pm on Friday.