In July 2023, DurAVR® THV was used for the first time in a ViV procedure as part of Health Canada’s SAP. A ViV procedure is required for patients with a life-threatening situation wherein their current bioprosthetic aortic valve is failing due to calcification or structural deterioration, and a new heart valve must be implanted inside the failing valve.
DurAVR® INVESTIGATIONAL USE ONLY. NOT AVAILABLE FOR COMMERCIAL SALE. EU: Exclusively for clinical investigations.
US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.
The DurAVR® THV System
The DurAVR® Transcatheter Heart Valve (THV) System delivers promising hemodynamic results#, combined with the deliverability performance of a balloon-expandable system. The System includes the DurAVR® THV, the ADAPT® anti-calcification tissue, and the ComASUR® Delivery System.
A balloon expandable valve with self-expanding hemodynamics is like the structural heart holy grail.
Dr Michael Reardon
Professor of Cardiothoracic Surgery, Allison Family Distinguished Chair of Cardiovascular Research Methodist DeBakey Heart & Vascular Center
The hemodynamics are so fantastic yet it has the ease, reliability, and accuracy of the balloon expandable valve … it combines all those things in a really well-designed valve.
Dr Rebecca T. Hahn
Director of Interventional Echocardiography at Columbia University
With DurAVR® we are seeing clinical results that look like a pre-disease state, with excellent hemodynamic performance and good laminar flow. In addition, it is incredibly easy to use.
Dr Chris Meduri
Interventional Cardiologist at Karolinska Institut and Anteris Chief Medical Officer
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DurAVR® Transcatheter Heart Valve
The DurAVR® Transcatheter Heart Valve (THV) is a novel biomimetic valve made from a single piece of native-shaped tissue. It is designed to mimic the performance of a pre-disease human aortic valve.
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Single-piece, Biomimetic Design
A single piece of ADAPT® tissue is molded to form native-shaped leaflets, designed to mimic the performance of a healthy aortic valve.
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Coronary Access
Large open cells in stent frame to improve coronary access.
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Balloon-Expandable Frame
Cobalt chromium frame expands with balloon inflation and is designed for controlled valve deployment and placement.
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ADAPT® Tissue Process
The tissue is a patented bovine tissue that has been clinically proven to be calcium-free for up to 10 years1 and has been distributed for use in over 55,000 patients globally (as a cardiac and vascular patch).2 ADAPT® tissue is moldable, allowing it to be shaped for use in the DurAVR® heart valve.
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ComASUR® Delivery System
The ComASUR® Delivery System is designed for controlled deployment and accurate placement of the balloon-expandable DurAVR® THV. The ComASUR® Delivery System is designed to achieve ideal valve positioning through precise alignment with the heart’s native commissures
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Balloon-Expandable Deployment
Familiar procedural steps designed to allow controlled expansion and predictable, reliable placement
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Precise Commissure Alignment
Provides controlled deployment and accurate alignment of the DurAVR® THV with the position of the native aortic valve
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Steerable Catheter
For a precise deflection through the heart anatomy in a controlled manner to avoid damage to the aorta
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Expandable Sheath
14Fr expandable sheath for vessel access
SPECIAL USE CASES
Valve-in-Valve
Transcatheter Valve-in-Valve (ViV) replacement is performed by implanting a transcatheter heart valve within a previously implanted bioprosthetic aortic valve that is failing.
These patients are at high risk for another surgery and require a minimally invasive treatment option. Canada’s SAP exists so that life-saving technology not currently available for commercial use in Canada can be provided when no other commercially available alternatives are suitable.
Promising Hemodynamic Performance
DurAVR® THV delivers outstanding hemodynamics, measured by Effective Orifice Area (EOA), Mean Pressure Gradient (MPG) and Doppler Velocity Index (DVI).
Early Feasibility Study Data | 30-Day TTE Data, n=15, mean annulus: 22.7 mm | Presented at EuroPCR 2024
References
# Cavalcante J. Biomimetic Design Restores Flow and Hemodynamics and Leads to Significant LV Mass Regression: update from First-in-Human (FIH) Study with novel DurAVR™ Transcatheter Heart Valve. Oral Presentation at: New York Valves; June 2024; New York, New York.
† Lim KH, Candra J, Yeo JH, and Durán C, Flat or curved pericardial aortic valve cusps: A finite element study. The Journal of Heart Valve Disease, 2004;13(5): 792-7.
Anteris Data on File.
- Neethling W, Rea A, Forster G, Bhirangi K. Performance of the ADAPT-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes, Front Pediatr, 2020;8:198
- Anteris Data on File