REVA Receives CE Mark for Its Bioresorbable Coronary Scaffold
REVA Medical has received a CE mark for its Fantom, which is a drug-eluting bioresorbable coronary scaffold.
The device is an alternative to using metal stents to treat coronary artery disease. Scaffolds restore blood flow, support the artery through the healing process, then disappear from the body over time. The resorption allows the return of natural movement and function of the artery, which is not possible with permanent metal stents.
The device scaffold is fully visible under x-ray.
The CE Mark application included data from a clinical trial involving 240 patients between March 2015 and March 2016. The major adverse cardiac event rate through six months for all 240 patients was 2.1 percent. — Cynthia Jessup