First Patients Enrolled in Trial of Reva Medical's Fantom Bioresorbable Scaffold

December 3, 2014—Reva Medical, Inc. announced the initiation of patient enrollment in the clinical trial program for the company’s Fantom bioresorbable drug-eluting scaffold.

Alexandre Abizaid, MD, who is the trial program’s coprincipal investigator, performed the first implantations of the Fantom device. Dr. Abizaid is Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil.

According to Reva Medical, Fantom is a fully bioresorbable sirolimus-eluting coronary scaffold that is designed to dissolve over time, leaving the artery free of a permanent implant and thereby allowing the artery to return to its natural vasomotion. Fantom is made from Reva’s polymer, which was developed specifically for scaffold performance. The polymer allows for scaffold strength in a thin-strut design, as well as ease-of-use features like single-step inflation and complete visibility of the scaffold under x-ray.

Reva Medical expects the Fantom scaffold will be its first commercial product. The device is currently in clinical studies, and the company will require successful clinical trial results and regulatory approval before it can commercialize Fantom or any other products.