FDAnews Device Daily Bulletin

UK’s NICE Begins Reviewing A-Fib Alternative Treatment

Nov. 22, 2010
The UK’s National Institute for Health and Clinical Excellence (NICE) is reviewing endoscopic laser balloon pulmonary vein isolation as a treatment alternative for patients with atrial fibrillation (A-Fib) that does not respond to medicine. The laser balloon treatment, which electrically isolates the pulmonary veins from the left atrium, recently got CE Marking, which allows it to be marketed in the European Economic Area. Although it’s a new technology, “there are a fair amount of cases being done with strict controls on how effective it’s been to use it,” Edward Rowland, president of Heart Rhythm UK and a member of NICE’s committee for new technologies, said.
International Medical Device Regulatory Monitor