REVA Medical has announced that it has been granted approval to conduct an expanded clinical trial for its Fantom bioresorbable scaffold in Germany. The Fantom 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 recent approval allows REVA to expand the scope of the FANTOM II clinical trial, which successfully enrolled 240 patients between March 2015 and March 2016. 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 in excess of 20mm in length.
Reggie Groves, REVA’s chief executive officer, comments: “The clinical results we have seen in our first 240 patients treated with Fantom have been excellent. But we know that coronary artery disease patients often have complicated disease, with longer lesions, and disease in multiple vessels. We believe Fantom’s unique features including a more forgiving implant technique, and the ability to visualize the complete scaffold structure under X-ray, will be advantageous when treating these more complex cases. We are excited to begin this next phase of clinical evaluation.”
Approval for the expanded trial was granted by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Norbert Frey, a FANTOM II trial investigator from the University of Kiel, will serve as the lead investigator. Patient enrolment will begin shortly, with the first cases to be highlighted at the upcoming EuroPCR conference, which will be held in May in Paris.