REVA Completes Clinical Enrollment Milestone
SAN DIEGO, REVA Medical, Inc. is pleased to announce that it has
enrolled the first cohort of 110 patients in the FANTOM II clinical trial.
Achievement of this milestone is key to the Company’s planned CE Mark
application of its Fantom® sirolimus-eluting
bioresorbable scaffold. The CE Mark application, planned for mid-2016, will be
based upon data from these patients through the six-month time point.
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, thus allowing the vessel to reestablish its ability to move naturally.
Didier Carrié, MD, PhD and Bernard De Bruyne, MD, PhD, two leading investigators from the trial commented on their experience using the Fantom scaffold. Dr. Carrié, from the Service de Cardiologie, CHU Toulouse Rangueil in France, commented, “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.” Dr. De Bruyne, from the Cardiovascular Center Aalst in Belgium further stated, “The ability to visualize the scaffold under x-ray sets Fantom apart from other bioresorbable scaffolds. This unique feature will make it easier for physicians to incorporate bioresorbable scaffold use into their practice.”
“Enrollment of these 110 patients represents a significant accomplishment for the Company,” commented Reggie Groves, REVA’s Chief Executive Officer. “It moves us one step closer to our goal of commercializing Fantom, which we believe offers the performance and ease-of-use features that will enable physicians to provide the best possible care for their patients.”
An update on the FANTOM clinical trial program will be presented at the Transcatheter Cardiovascular Therapeutics (“TCT”) Conference, which will be held October 11th through 15th in San Francisco, California.
Source: Reva
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