According to a press release from Reva Medical, the first cohort of 110 patients has been enrolled in the FANTOM II clinical trial. The company hopes to use six-month data, when available, from the study when it applies for the CE mark for its Fantom sirolimus-eluting bioresorbable scaffold. It plans to apply for the CE mark next year.
The press release reports that the Fantom scaffold, made from Reva’s 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, thus allowing the vessel to re-establish its ability to move naturally.
Didier Carrié (Service de Cardiologie, CHU Toulouse Rangueil, France), says: “I have been very pleased with how easy Fantom is to implant. The delivery to the target lesion has been successful in our cases and the single-step inflation reduces the overall procedure time.”
An update on the FANTOM clinical trial programme will be presented at the Transcatheter Cardiovascular Therapeutics meeting (11–15 October, San Francisco, USA)