Reva Medical's FANTOM II Clinical Trial Expanded to Europe

April 22, 2015—Reva Medical, Inc. announced that the FANTOM II clinical trial of the company’s Fantom sirolimus-eluting bioresorbable scaffold is enrolling patients in Europe. In March, the study began enrolling patients in Brazil. The Fantom scaffold is designed to allow the restoration of blood flow in patients being treated for coronary artery disease, and then resorb into the body over time, leaving no trace.

The FANTOM II trial is enrolling patients to support of the company’s application for European CE Mark approval, which is expected to occur by mid-2016. Initial data from the Fantom clinical trial program will be presented in the EuroPCR 2015 conference, which will be held May 19–22 in Paris, France.

The first patient implantation in Europe was performed by Jens Flensted Lassen, MD, from Rigshospitalet, University of Copenhagen, Denmark. In the company’s announcement, Dr. Lassen commented, “I was impressed with the ease of delivery of Fantom to the lesion site, and further appreciated the ability to clearly visualize the complete scaffold during the procedure. Fantom was simple to implant and the angiographic result was excellent. I look forward to playing a significant role in treating patients’ coronary artery disease with the Fantom scaffold.”