FDA Approves Anteris Technologies’ DurAVR THV Global Trial

Anteris Technologies Global Corp. has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial designed to evaluate the DurAVR Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis. The study also will be used to support a future PMA* submission.

“We are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States.** 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 technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition,” Anteris Technologies Vice Chairman/CEO Wayne Paterson said. 

The PARADIGM trial is co-chaired by Dr. Michael J. Reardon, Allison Family Distinguished Chair of Cardiovascular Research and Cardiothoracic Surgery professor at the Houston Methodist Hospital, Texas; and Professor Stephan Windecker, chairman of the Department of Cardiology at Bern University Hospital, Switzerland.

The PARADIGM trial is a prospective randomized controlled trial (RCT) that will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs). PARADIGM stands for a Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices.

This head-to-head study will enroll approximately 1,000 patients in the United States, Europe, and Canada in the ‘All Comers Randomized Cohort’ with one-to-one patient randomization; participants will receive either the DurAVR THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year after the procedure.

The PARADIGM Trial is designed to provide the clinical evidence necessary to support an FDA Premarket Approval application in the United States, with CE Mark approval expected to progress concurrently to the PMA.

The DurAVR Transcatheter Heart Valve (THV) was designed in partnership with interventional cardiologists and cardiac surgeons to treat aortic stenosis—a potentially life-threatening condition resulting from aortic valve narrowing. The balloon-expandable DurAVR THV is the first biomimetic valve shaped to mimic the performance of a healthy human aortic valve that aims to replicate normal aortic blood flow. DurAVR THV is made using a single piece of molded ADAPT tissue, Anteris’ patented anti-calcification tissue technology. The FDA-cleared ADAPT tissue has been used clinically for more than a decade and distributed for use in over 55,000 patients worldwide. The DurAVR THV System is comprised of the DurAVR valve, the ADAPT tissue, and the balloon-expandable ComASUR Delivery System.

Anteris Technologies is a global structural heart company that designs, develops, and commercializes medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.

*A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs minimize bias and allow a clear comparison between treatment groups.

**Subject to Institutional Review Board (IRB) approval