REVA has reached its targeted patient enrolment of 110 for Cohort B of the FANTOM II clinical trial. This brings the total enrolment to 227 patients.
FANTOM II is a clinical study of the safety and performance of the Fantom sirolimuseluting bioresorbable coronary scaffold. Patients have been enrolled at clinical sites in eight countries outside of the USA.
Reggie Groves, REVA’s chief executive officer, says, “With this trial and additional trials that we may initiate in the future, our goal is to build a strong foundation of positive clinical data for Fantom that establishes it as a safe and effective treatment for patients suffering from coronary artery disease.”
On September 30, 2015, the Company announced it had achieved the targeted enrolment of 110 patients in the first cohort of the trial (Cohort A). Seven additional patients were subsequently enrolled in this cohort. Patients in Cohort A are currently undergoing a six-month imaging assessment, and data from these patients will be used in a CE mark application planned for the third quarter of 2016. REVA plans to provide the six-month data on a subset of patients in Cohort A at the 2016 Paris Course on Revascularization (EuroPCR).
The data from patients in Cohort B is intended to provide further clinical evidence regarding the use of Fantom to treat coronary artery disease and will be used for market support and other commercial purposes. Data from these patients are planned to be released at industry conferences, beginning at the Transcatheter Cardiovascular Therapeutics (TCT) conference in October 2016.