Ann: Three ViV Patients Completed under Health Canada SAP, page-22

The Canadian Special Access Program allows doctors to request use of the DurAVR on a case by case basis, it's not a blanket approval, but any implantation we do can be added to the evidence when it comes to a submission for an approval anywhere. How many patients would we need for an approval? The Sapien initial approval in Canada was based off two studies that totaled 667 patients. The next gen Sapien 3 was approved via a 40 patient study but that was because the platform was already approved.

Is there a TAVR device approved for ViV in Canda? I can't find info on any specific device but Dr Asgar's quote in the press release does make it sound like there is a limited commercial option or options so ViV is probably not a totally unmet need, although he obviously took the extra steps to use the DurAVR because he thinks it's superior.

6 patients won't lead to an approval and with replacement heart valves being the in the highest classification as they are in the US (Class 4 in Canada vs Class 3 in the US), my guess is that we'll still need a large number of trial patients in Canada just like in the US to prove safety before we get an approval. So I think our large upcoming US pivotal trial will likely will serve both a US and Canada approval. Is there a way to expedite the process in Canada? Maybe but it's always important to remember that being a life sustaining device means that studies will have to be very robust with large enough patient populations to ensure safety.