Reva Medical has announced that more than 200 patients have been enrolled in its clinical study of its sirolimus-eluting bioresorbable coronary scaffold (Fantom). The company has also said that it is on track with its plans to commercialise the scaffold.
The Company previously announced the enrolment of a first set of 110 patients, who are now undergoing a six-month imaging assessment. The clinical data for these patients is planned to be collected during the second quarter and used in a CE mark application in the third quarter of this year. If Reva does receive CE mark approval for its scaffold, it will enable the company to sell Fantom in Europe and in other countries that recognise the CE mark. In addition to this first set of patients, the company began enrolling a second set of 110 patients during the fourth quarter of 2015 and is poised to complete the full enrolment of at least 220 patients by the end of this fiscal quarter. Data from the second set of patients will be used for market support and other commercial purposes.
According to a press release, acute clinical data for Fantom – presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) conference last October – indicates that the device is associated with a good rate of procedural success and a low rate of major adverse cardiac events (MACE). The press release reports that subsequent data is due to be released in the early part of this year.