Anteris Technologies Receives European Regulatory Clearance for DurAVR Global Pivotal Trial in Aortic Stenosis
核心洞察
Anteris Technologies received regulatory clearance from the Danish Medicines Agency (搜索) to initiate the global PARADIGM Trial for its DurAVR (搜索) transcatheter heart valve in patients with severe calcific aortic stenosis (搜索).
The prospective randomized controlled trial will enroll approximately 1,000 patients to evaluate the safety and effectiveness of the biomimetic DurAVR (搜索) valve compared to commercially available TAVR devices.
Patient recruitment at Danish centers is expected to begin in Q4 2025, with planned expansion across the United States, Europe, and Canada pending additional regulatory approvals.
Anteris Technologies Global Corp (搜索). has achieved a significant regulatory milestone with the Danish Medicines Agency (搜索)'s clearance to initiate the global PARADIGM Trial for its DurAVR (搜索) Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis (搜索). Patient recruitment at Danish centers is expected to begin in the fourth quarter of 2025, marking the launch of this pivotal study designed to support global regulatory approvals.
PARADIGM Trial Design and Objectives
The PARADIGM Trial represents a prospective randomized controlled trial that will evaluate the safety and effectiveness of the DurAVR (搜索) THV compared to commercially available transcatheter aortic valve (搜索) replacements (TAVRs). This head-to-head study will enroll approximately 1,000 patients in the "All Comers Randomized Cohort" with 1:1 randomization between the DurAVR THV and commercially available THVs.
The trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure. According to the study protocol registered under ClinicalTrials.gov ID NCT07194265, the planned expansion across other geographies includes additional cohorts.
Biomimetic Valve Technology
The DurAVR (搜索) THV distinguishes itself as the first biomimetic valve, designed to mimic the performance of a healthy human aortic valve (搜索) and replicate normal aortic blood flow. The balloon-expandable device is constructed using a single piece of molded ADAPT tissue (搜索), Anteris' patented anti-calcification tissue technology that has been FDA-cleared and used clinically for over 10 years in more than 55,000 patients worldwide.
"The PARADIGM Trial enables us to bring promising new technology to patients across all surgical risk groups, building on the growing body of evidence supporting the DurAVR (搜索) THV's favorable hemodynamic performance," said Dr. Michael Reardon and Professor Stephan Windecker, Study Co-Chairs of the global PARADIGM Trial.
Global Expansion Strategy
With the first regulatory clearance secured, Anteris is positioned to expand the PARADIGM Trial through the addition of further countries and sites in the near term, with planned expansion across the United States, Europe, and Canada. An Investigational Device Exemption (IDE) application remains under review by the U.S. Food and Drug Administration (搜索), with Anteris expecting FDA approval in the near term.
"Receiving initial approval in Europe is an important milestone as it signals the launch of the global PARADIGM Trial. This groundbreaking study has been designed with world-leading experts and is attracting significant interest from clinicians globally, reflecting the potential for DurAVR (搜索) to transform care for patients with aortic stenosis (搜索)," said Anteris Chief Medical Officer Chris Meduri, M.D.
Regulatory Pathway and Commercial Implications
The PARADIGM Trial is designed to generate Level 1 evidence through randomized controlled trials, which are generally considered the highest level for determining the effectiveness of interventions in evidence-based medicine. This approach aims to support both Premarket Approval (PMA) applications in the United States and CE Mark approvals in Europe.
"The PARADIGM trial is a multi center global study which, if successful, will result in multiple approvals and labels for the DurAVR (搜索) THV. This is a watershed moment in the company's life cycle and marks the beginning of the commercialization planning phase as we march towards global approvals," said Vice Chairman and CEO Wayne Paterson.
Clinical Context and Unmet Need
Aortic stenosis (搜索) represents a potentially life-threatening condition resulting from the narrowing of the aortic valve (搜索). The DurAVR (搜索) THV was developed in partnership with leading interventional cardiologists and cardiac surgeons to address this critical cardiovascular condition. The DurAVR THV System comprises the DurAVR valve, the ADAPT tissue (搜索), and the balloon-expandable ComASUR Delivery System.
Management believes strong enthusiasm from investigators is expected to translate into efficient recruitment and timely study advancement, positioning the company to provide access to an increasing pool of patients globally who could benefit from this technology.