Reva Medical's Fantom Bioresorbable Coronary Scaffold Approved in Europe
April 10, 2017—Reva Medical, Inc. announced it has received European CE Mark approval for its Fantom drug-eluting bioresorbable coronary scaffold. Fantom is Reva’s first commercial product. The Fantom scaffold is made from Reva’s advanced polymer and is designed to allow the restoration of blood flow in patients with coronary artery disease, then resorb from the body over time.
Reva will begin selling in selected centers in Europe this quarter. Initial quantities of the product have been manufactured and are immediately available to support commercialization.
According to Reva Medical, data from the company’s FANTOM II clinical trial were used to support the application for CE Mark approval. The FANTOM II trial enrolled a total of 240 patients between March 2015 and March 2016. The major adverse cardiac event (MACE) rate through 6 months for all 240 patients is 2.1%, which compares favorably to commercial first-generation bioresorbable scaffolds. The company continues to follow and evaluate patients and plans additional data releases at major industry conferences in May and October of this year.
As previously announced, Reva Medical is currently pursuing private financing to support its commercial launch of Fantom and its ongoing operating and capital needs, including follow-up clinical trials and new product feasibility work. The financing is anticipated to close before the end of April.
In related news, the company also recently announced it has been granted approval to expand the scope of the FANTOM II clinical trial in Germany. The primary objective of the expanded study is to evaluate the safety and effectiveness of Fantom in a more complex patient population, treating up to two lesions in one or more coronary arteries, and lesions with lengths in excess of 20 mm.
Approval for the expanded trial was granted by Germany's Federal Institute for Drugs and Medical Devices. Dr. Norbert Frey, a FANTOM II trial investigator from the University of Kiel, will serve as the lead investigator. Patient enrollment will begin shortly, with the first cases to be highlighted at the 2017 EuroPCR conference, which will be held on May 16–19 in Paris, France.