The reason a 12 month duration isn't on the general info sections of the FDA's website is because trials are specific to the class and type of medical device, and trial phase. 12 months has been assumed because that's the follow-up duration of the FIH trial in Georgia, as you can see from the link to the Clinical Trials website I posted above.
I don't see any way to get an approval based on the EFS study, not even with the FIH data added. There's a reason it's called "early feasibility". We'll need a larger pivotal trial. According to Wayne, we'll be able to generate revenue from the cost of the DurAVR's used during the trials and there is the possibility, as shown in a photo from one of his presentations, of us being eligible for a Humanitarian Device Exemption, which could allow us to implant 8,000 DurAVR's outside of the trials. Those require the use in a patient population with a relatively rare condition so he must have his sights on a small subset of potential valve replacement patients which would qualify us for that distinction.
Add to My Watchlist
What is My Watchlist?
