Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has received US Food and Drug Administration (FDA) approval to initiate PARADIGM, a global Investigational Device Exemption (IDE) pivotal study evaluating the DurAVR® Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis. The trial is intended to support a future Premarket Approval (PMA) submission in the United States, with CE Mark activities to progress in parallel.
The PARADIGM trial is a prospective, randomised controlled study evaluating the safety and effectiveness of the DurAVR® THV against commercially available transcatheter aortic valve replacement (TAVR) devices.
About 1,000 patients will be enrolled across the United States, Europe and Canada in an “All Comers” randomised cohort, with 1:1 assignment to DurAVR® THV or an approved, commercially available THV. The primary endpoint tests non-inferiority on a composite of all-cause mortality, any stroke and cardiovascular hospitalisation at 12 months post-procedure.
Design and objectives:
- Type: Prospective, randomised controlled trial (RCT) directly comparing DurAVR® THV with commercially available transcatheter aortic valve replacement (TAVR) systems.
- Enrolment: Around 1,000 “all-comers” patients across the United States, Europe and Canada, randomised 1:1 to DurAVR® THV or an approved commercial TAVR.
- Primary endpoint: Non-inferiority on a composite of all-cause mortality, any stroke, and cardiovascular hospitalisation at one year post-procedure.
- Purpose: To generate robust clinical evidence for an FDA PMA filing; European CE Mark pathways are expected to advance alongside the PMA process.
“We are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States,” AVR vice chairman and CEO Wayne Paterson said. “This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition.”
PARADIGM is co-chaired by Dr Michael J. Reardon, Allison Family distinguished chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at Houston Methodist Hospital (Texas), and Professor Stephan Windecker, chairman of Cardiology at Bern University Hospital (Switzerland).
Raising $38.5M
Anteris has received binding commitments for a placement of about A$38.5 million (US$25.2 million) to fund patient recruitment and execution of the PARADIGM global pivotal trial of the DurAVR® transcatheter heart valve, and to expand manufacturing capacity.
The money will fund the next phase of growth and execution of the company’s clinical strategy. Planned uses include recruitment for the DurAVR® THV global pivotal study in aortic stenosis (the PARADIGM Trial), ongoing study operations, and expansion of manufacturing capacity. A portion will support continuing R&D for v2vmedtech inc., with the remainder allocated to working capital and general corporate purposes.
Read more: Anteris raises A$38.5M to accelerate PARADIGM pivotal trial and manufacturing scale-up
What is PARADIGM?
PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices.