Topic: bioresorbable stent
Reva Medical expanded its operations to seven European countries, while it looks to build up clinical evidence for its bioresorbable stents.
Reva netted a CE mark for the first drug-eluting bioresorbable scaffold in lower-leg peripheral artery disease, and the company’s first in the space.
The European regulatory nod clears Reva to push a device it thinks addresses some shortcomings of other products in the sector.
The decision to can the program follows a succession of setbacks for Abbott’s rival stent that have dented the sector’s hopes of generating big sales.
Reva Medical has secured a CE mark for its drug-eluting bioresorbable coronary scaffold, Fantom.
The FDA warned of a higher rate of cardiac events in patients receiving Abbott's Absorb stent compared to those treated with a metal stent.
Though there are many benefits to fully bioresorbable stent, the technology’s novelty gives rise to several challenges, said a group of U.S. and European cardiologists at a roundtable discussion Thursday.