Anteris Technologies Global Receives French Regulator's Approval for DurAVR Trial in Aortic Stenosis
MT Newswires Live
Jun 08
Anteris Technologies Global (AVR) received the French National Agency for Medicines and Health Products Safety's approval for the DurAVR transcatheter heart valve's global trial in patients with severe calcific aortic stenosis, the company said Monday.
The approval allows Anteris to start patient recruitment, targeting to enroll about 1,000 subjects to assess DurAVR's non-inferiority on a primary endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization one year after the procedure, according to the statement.
Anteris said it also has ongoing site activations and patient enrollment in the US and across Europe.
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