Posted by Michael Wonder on 14 Jun 2017
How creative FDA regulation led to first-in-the-world approval of a cutting edge heart valve
14 June 2017 - Nearly six years ago FDA approved an artificial transcatheter heart valve to treat patients having severe symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms, or cardiac arrest, because one of the valves in their heart (the aortic valve) was no longer working properly and they were too sick for surgery.
Transcatheter aortic valve replacement (TAVR) has revolutionised the treatment of these patients. But the U.S. wasn’t the trendsetter – in fact, it was the 42nd country to approve the first TAVR device, the Edwards Sapien THV.
