"The Humanitarian Device designation would allow us to sell up to 8,000 DurAVR's per year but that designation does require that there be no comparable device approved and available."
If this is correct this is excellent news for us.
There are currently no comparable devices to the DurAVR in treating VIV patients, in the outcomes the DurAVR guarantees (metrics better than the original implanted device.) None. No other device has ever done this, therefore there are no comparable devices....
Based on the definition and criteria you provided above it is my strong belief that the DurAVR will secure Humanitarian Device approval.
AVR Price at posting:
$19.80 Sentiment: Buy Disclosure: Held
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