News | June 05, 2015

REVA Initiates FANTOM II Clinical Trial

Live case shown at ACC meeting in San Diego

Fantom, REVA Medical, FANTOM II trial, ACC

Fantom image courtesy of REVA Medical Inc.

June 5, 2015 - REVA Medical Inc. announced the initiation of patient enrollment in the FANTOM II clinical trial of its Fantom sirolimus-eluting bioresorbable scaffold in March. The scaffold, made from REVA's advanced proprietary polymer, is designed to allow the restoration of blood flow in patients being treated for coronary artery disease, then resorb from the body over time.

The FANTOM II trial will enroll patients at multiple clinical sites in eight countries. Data from up to 110 patients in this trial is intended to be used in a European CE Mark application, which is expected to occur by mid-2016.

Alexandre Abizaid, M.D., co-principal investigator for the FANTOM II trial, and his team at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil performed the first two patient implants of the Fantom scaffold; one of the implants was broadcast during a live video satellite transmission at the American College of Cardiology's (ACC) 64th annual scientific session & expo, held March 14-16 in San Diego, California.

The live implant of the Fantom scaffold involved a patient that presented with a 70 percent blockage of the left anterior descending artery of the heart. The Fantom scaffold was clearly visible during the procedure, easily delivered to the location of the blockage, and expanded to its intended diameter in a standard clinical procedure to restore blood flow.

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