Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has welcomed positive feedback from the United States Federal Drug Administration (FDA) in a pre-submission meeting for a study assessing the DurAVR™ THV transcatheter aortic valve replacement.
AVR is developing DurAVR™ THV as a new class of transcatheter aortic valve replacement (TAVR), the world’s only balloon-expandable, single-piece biomimetic aortic replacement valve shaped to mimic the native human valve.
The FDA has indicated support for key design aspects of AVR’s proposed trial, clearing the way for further refinement.
On path to commercialisation
“Receiving this feedback from the FDA is an important milestone as we continue our progress toward study approval and completion,” Anteris Technologies CEO and managing director Wayne Paterson said.
“We are appreciative of the ongoing and close collaboration with the FDA as we now prepare the final stages of the submission process.
“This is the final study on the path to marketing approval for DurAVR™.”
AVR sought to confirm the main structure of the study in its dialogue with the FDA, which will include the following elements:
- Structured as an International Study; meaning sites outside of the US can participate in the study.
- Randomization of DurAVR against commercially available TAVR.
- Non-inferiority as primary study goal.
- Primary composite endpoint of Death, Stroke and Rehospitalisation.
- Inclusion of all patient risk stratifications (high, intermediate, low).
The FDA also indicated that a single-arm, valve-in-valve registry to run concurrently with the primary aortic stenosis arm is also acceptable.
AVR says the study will be the first randomised all risk head-to-head registration trial for TAVR, and the company expects it to generate interest from both the medical and regulatory communities.
Anteris will submit its pivotal Investigational Device Exemption (IDE) including the proposed study design pending completion of the FDA-required animal and bench tests, which are currently ongoing.