Transcatheter Valves (2012 Prix Galien USA Winner)
The Prix Galien USA award for medical devices actually went to two devices in 2012: Edwards Lifesciences's Sapien TAVR and Medtronic's Melody transcatheter pulmonary valve.
Both devices represent the promising field of transcatheter heart valves. The valves so far have been reserved for patients at high risk of traditional open heart surgery. But their use is expanding. Edwards's Sapien 3 valve this year became the first TAVR valve to receive an expanded FDA indication that included patients with intermediate risk of dying or suffering serious complications during open-heart surgery, versus the previous indication for only high risk patients.
The next frontier for the technology? It's transcatheter mitral valve replacement.
[Image courtesy of Edwards Lifesciences]