Wonder what Dr. Perin needs to do in order for a confirmatory heart failure trial to take place. What‘s this new catheter system? Is it being looked at by the FDA? The excerpt below is from an October 2023 interview with Dr. Perin and the context was the DREAM-HF trial which was completed and the way forward.
“This time, his primary endpoint will be tailored to suit the positive outcome he knows he’ll be able achieve. This next round will begin in 2024.Once the FDA approves a new catheter system for injecting the heart with stem cells and genes, the team will proceed with new studies.”
Dr.Perin sounded pretty definitive about the timing of the expected trial. What does he know?
Full interview here:
https://houston.innovationmap.com/texas-heart-institute-emerson-perin-to-end-heart-failure-2665717236.html
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-512
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