Reva Medical's FANTOM II Trial Enrolls First Cohort of Patients

October 1, 2015—Reva Medical, Inc. announced that it has enrolled the first cohort of 110 patients in the FANTOM II clinical trial of the Fantom sirolimus-eluting bioresorbable scaffold. The trial’s 6-month follow-up data on these patients will support the company’s application for CE Mark approval of the device, which the company plans to submit in mid-2016.

The Fantom scaffold is composed of Reva’s proprietary polymer. It is designed to allow the restoration of blood flow in patients being treated for coronary artery disease, then resorb from the body over time, thus allowing the vessel to reestablish its ability to move naturally.

In the company’s announcement, Didier Carrié, MD, and Bernard De Bruyne, MD, who are leading investigators in the trial, commented on their experience using the Fantom scaffold. Dr. Carrié is with the Service de Cardiologie, CHU Toulouse Rangueil in France. Dr. De Bruyne is with the Cardiovascular Center Aalst in Belgium.

Dr. Carrié stated, “I have been very pleased with how easy Fantom is to implant. The delivery to the target lesion has been successful in our cases and the single-step inflation reduces the overall procedure time.”  

Dr. De Bruyne added, “The ability to visualize the scaffold under x-ray sets Fantom apart from other bioresorbable scaffolds. This unique feature will make it easier for physicians to incorporate bioresorbable scaffold use into their practice.”

Reva Medical noted that an update on the FANTOM clinical trial program will be presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific session, being held October 11–15 in San Francisco, California.