Reva Medical Inc. has announced that it has initiated patient enrollment into a clinical trial with its ReZolve2 bioresorbable sirolimus-eluting coronary scaffold.
ReZolve2 is a polymer scaffold designed to provide all of the proven benefits of a metal drug-eluting stent, with the advantage of fully resorbing from the body after it is no longer needed and allowing the artery to return to its natural function. Reva will evaluate the safety and performance of ReZolve2 in up to 125 patients at multiple centers in Australia, Brazil, Europe and New Zealand to provide the data needed to apply for European CE marking.
The first patient implants were performed by Dr. Alexandre Abizaid, chief of coronary interventions at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, and his team. Abizaid is a renowned interventional cardiologist and the principal investigator for Reva’s previous clinical trial of its bioresorbable scaffold, ReZolve, which was initiated in December 2011.
“We were pleased with the outcome of the procedures and saw a noticeable improvement in the deliverability of the ReZolve2 scaffold as compared to the original ReZolve device,” commented Abizaid. “The improved deliverability, together with the X-ray visibility of the ReZolve2 scaffold, proved to be excellent features of the product. We are excited to be involved in the clinical evaluation of this newest bioresorbable scaffold technology.”
Commenting on the initiation of patient enrollments, REVA’s Chairman and CEO, Bob Stockman said, “We are most appreciative to Dr. Abizaid and his team to lead the trial efforts of our newest product. ReZolve2 ushers in what we believe to be the most advanced technology in fully bioresorbable drug-eluting scaffolds. Now that the clinical evaluation of ReZolve2 is underway, we look forward to providing trial updates in the months ahead.”
Source: Reva Medical, Inc.