Ann: Latest Patient Group Show Best Results to Date at 30 Days, page-102

I'd dearly love to be wrong but I'm still very skeptical that we can get a humanitarian exception for valve-in-valve because the FDA's requirements specify that to receive the exemption there can be no approved options for the procedure. There are approved TAVR devices currently used for patients that need valve-in-valve replacements.

I just don't see why under their very explicit guidelines that the FDA would allow hundreds to thousands of patients to be implanted with a device without the device completing a large pivotal trial safely when there are already devices on the market that have completed such trials satisfactorily.