Reva Medical Presents Initial Clinical Results for Fantom Scaffold

May 21, 2015—Reva Medical, Inc. announced that initial clinical data on a subset of patients treated with the Fantom sirolimus-eluting bioresorbable scaffold were presented by Alexandre Abizaid, MD, during the Cardiovascular Innovations Pipeline session at the EuroPCR 2015 conference held May 19–22 in Paris, France. Dr. Abizaid, the Coprincipal Investigator of the Fantom clinical trial program, is Director of Invasive Cardiology at the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil.

According to the company, the FANTOM I pilot clinical trial enrolled patients treated with the Fantom scaffold at two sites in Brazil and Poland to provide early clinical data on the device. In these patients, acute performance was demonstrated with 100% technical and procedural success and no reported major adverse cardiac events to date, with no incidence of ischemic target lesion revascularization, myocardial infarction, or stent thrombosis.

The company advised that patients are being enrolled in the FANTOM II trial, which is designed to provide the necessary data for an application for European CE Mark approval of the Fantom device. Initial data from the FANTOM II trial, along with continued follow-up data from patients enrolled in the pilot clinical trial, will be presented at TCT 2015, which will be held in October 11–15 in San Francisco, California.