How creative FDA regulation led to first-in-the-world approval of a cutting-edge heart valve

Jeffrey Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health By: Jeffrey Shuren, M.D., J.D., and Bram Zuckerman, M.D. Nearly six years ago FDA approved an artificial transcatheter heart valve (THV) 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 revolutionized 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. Since that approval, FDA has sharpened its focus on patient access to innovative medical devices. On June 5th, 2017, FDA became the first regulatory body in the world to approve the most recent iteration of the Sapien valve, the Sapien 3, to treat high-risk patients whose surgically-placed aortic or mitral bioprosthetic valves were old and worn out. The Sapien 3 is intended to slip into these valves using a so-called “valve-in-valve” option, a procedure that can be done without open heart surgery through a patient’s blood vessel or a small cut in the chest. To narrow the gap from 42nd to first required creativity and commitment. The FDA Heart Valve Review Team first streamlined FDA’s expectations for nonclinical testing – somethin...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news