Reva Medical Expands FANTOM II Clinical Trial to Australia

May 14, 2015—Reva Medical, Inc. announced the expansion of the FANTOM II clinical trial to Australia, where the trial is enrolling patients for treatment with the Fantom sirolimus-eluting bioresorbable scaffold. David Muller, MD, performed the first implantation in Australia. Dr. Muller is Director, Cardiac Catheterization, at St. Vincent’s Hospital in Sydney, Australia.

According to the company, the FANTOM II trial will enroll up to 110 patients at multiple clinical sites in eight countries. The trial is evaluating the Fantom device to support an application for European CE Mark approval, which is expected to occur by mid-2016.

The trial’s coprincipal investigator, Alexandre Abizaid, MD, successfully performed the trial's first two patient implantations at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil. One of these procedures was broadcast during a live video satellite transmission at the American College of Cardiology’s 64th annual scientific session, held March 14–16 in San Diego, California.

On April 22, the first patient implantation in Europe was performed by Jens Flensted Lassen, MD, from Rigshospitalet at the University of Copenhagen in Denmark. In a company press release at that time, 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.”

The Fantom scaffold is made from Reva’s advanced polymer and is designed to allow the restoration of blood flow in patients being treated for coronary artery disease, then resorb from the body over time. Fantom is designed to offer both thinness and strength. Ease-of-use features include complete scaffold visibility under x-ray, expansion with one continuous inflation, and no procedural time limitations.

The Fantom, which will be the company’s first commercially available product, is currently an investigational device and is not commercially available in any markets, advised Reva Medical.