Anteris Technologies Initiates U.S. Enrollment in PARADIGM Trial for Novel Biomimetic Heart Valve
核心洞察
Anteris Technologies (搜索) has secured CMS reimbursement eligibility for its PARADIGM Trial under the TAVR National Coverage Determination, facilitating U.S. site activation for the pivotal study.
The first U.S. patients have been successfully enrolled and treated in the PARADIGM Trial at Montefiore Medical Center, marking a significant milestone for the global study.
The PARADIGM Trial will evaluate the DurAVR® THV (搜索), the first biomimetic transcatheter heart valve, against commercially available TAVRs in approximately 1,000 patients with severe calcific aortic stenosis (搜索).
Anteris Technologies (搜索) has achieved a significant regulatory milestone by securing U.S. Medicare reimbursement eligibility for its global pivotal PARADIGM Trial, followed by the successful enrollment and treatment of the first U.S. patients with its novel biomimetic transcatheter heart valve. The procedures were performed by Dr. Azeem Latib at Montefiore Medical Center in New York, representing a critical advancement in the evaluation of next-generation heart valve technology.
CMS Reimbursement Approval Accelerates Trial Progress
The Centers for Medicare & Medicaid Services (搜索) (CMS) approved reimbursement eligibility for the PARADIGM Trial under the Transcatheter Aortic Valve (搜索) Replacement (TAVR) National Coverage Determination 20.32. This approval operates under a Coverage with Evidence Development (CED) model, enabling reimbursement while generating clinical evidence through the trial. The milestone is expected to facilitate U.S. site activation and accelerate operational momentum across participating centers.
"Following CMS approval, the Anteris team and our physician partners worked closely together to achieve first patient enrollments within the week," said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. "This marks a major milestone for the PARADIGM Trial as our U.S. study sites come on line and expand recruitment capability."
First U.S. Patients Successfully Treated
Dr. Azeem Latib, Principal Investigator and Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore, performed the first U.S. procedures in the PARADIGM Trial. His early experience with the DurAVR® THV (搜索) System has been highly encouraging.
"Performing the first U.S. cases in the global PARADIGM Trial is a significant achievement for trial investigators, and our early procedural experience with the DurAVR® THV (搜索) System has been highly encouraging," said Dr. Latib. "PARADIGM is specifically designed to answer clinically meaningful questions and go beyond the usual safety metrics and hemodynamics by also looking at the impact of flow patterns on left ventricular recovery."
PARADIGM Trial Design and Objectives
The PARADIGM Trial is a prospective randomized controlled trial designed to evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve compared to commercially available transcatheter aortic valve (搜索) replacements. 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 (搜索) and commercially available and approved 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. The study is registered under ClinicalTrials.gov NCT07194265.
Innovative Biomimetic Valve Technology
The DurAVR® THV (搜索) represents a significant technological advancement 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 valve was developed in collaboration with leading interventional cardiologists and cardiac surgeons to treat aortic stenosis (搜索), a potentially life-threatening condition resulting from the narrowing of the aortic valve.
The valve is constructed using a single piece of molded ADAPT® tissue (搜索), Anteris' patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The complete DurAVR® THV (搜索) System comprises the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System (搜索).