REVA Medical released initial clinical data on a subset of patients treated with the Fantom sirolimus-eluting bioresorbable scaffold at the EuroPCR 2015 meeting (19–22 May, Paris, France). Reporting the results was Alexandre Abizaid, director of invasive cardiology at the Institute Dante Pazzanese of Cardiology, in Sao Paulo, Brazil, and co-principal investigator for the Fantom clinical trial programme.
The FANTOM I pilot clinical trial, which enrolled patients with the Fantom scaffold at two clinical sites in Brazil and Poland, was designed to provide early clinical data on the device. In these patients acute performance was demonstrated with 100% technical and procedural success and no reported major adverse cardiac events (MACE) to date, with no incidence of ischaemic target lesion revascularisation, myocardial infarction or stent thrombosis.
“We are pleased with the early clinical results we are seeing with the Fantom scaffold,” stated Jeff Anderson, REVA’s senior vice president of clinical and regulatory affairs. “In the patients that have completed their four-month angiographic assessment we have observed that the scaffold is performing well and the treated vessels remain widely patent.”
REVA is currently enrolling patients in the FANTOM II trial, which is designed to provide the necessary data for a European CE mark application of Fantom. Initial data from the FANTOM II trial, along with continued follow-up data from patients enrolled in the pilot clinical trial, will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference (11–15 October, San Francisco, USA).