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Clinical Evidence

Promising Hemodynamic Performance

 

DurAVR® THV delivers promising hemodynamic results, measured by Effective Orifice Area (EOA), Mean Pressure Gradient (MPG) and Doppler Velocity Index (DVI).

 

Mean Annulus: 22.2mm


First‐In‐Human Data (1 Year)

Early Feasibility Study Data

Wagoner T. Oral Presentation at: CRT Conference, March 2024; Washington, USA

Mean Annulus: 22.73mm

First‐In‐Human Data (1 Year)

First‐In‐Human Data (1 Year)

Cavalcante J. Oral Presentation at: New York Valves; June 2024; New York, New York.
*One subject died of a non-cardiac death before reaching 1-year follow-up.

DurAVR® THV restores near-normal flow dynamics

When compared to a healthy aortic valve, DurAVR® THV showed no significant difference in flow.

 

FD = Flow Displacement
FRR = Flow Reversal Ratio


Healthy aortic valve vs DurAVR® THV: No significant difference in flow (p>0.05)
FIH Study, Presented at New York Valves 2024.

DurAVR® THV Met Targeted Safety Endpoints

High implant success with a good safety profile was demonstrated.

 

Values are n (%)

*Subject had pre-existing significant conduction abnormalities with prolonged QRS 
EFS Safety Data30 Days (n=15)
Primary Safety Endpoints 
All-cause Mortality or Disabling Stroke 0
Secondary Safety Endpoints 
All-cause Mortality0
Disabling Stroke 0
VARC-3 Type 2-4 Bleeding0
Major Vascular or Structural Heart Complications 0
Acute Kidney Injury (AKI) Stage 3 or 4 0
Moderate or Severe Aortic Regurgitation 0
New Permanent Pacemaker1 (6.7)*
Surgery or Intervention Related to the Device, including Aortic Valve Reintervention 0
Values are n (%)
*Non-cardiac death
**Final stroke disability grade pending 90-day assessment (VARC-3)
***Subjects had pre-existing significant conduction abnormalities with prolonged QRS
FIH Safety Data≤30 Days
(n=41)		>30 days
(n=20)
Primary Safety Endpoints
All-cause Mortality01 (5)*
Myocardial Infarction00
Disabling Stroke00
Life-threatening Bleeding00
Secondary Safety Endpoints
Valve-related Mortality00
All Strokes1 (2.4)**0
All Bleeding2 (4.9)0
Major Access Site / Vascular Complications4 (9.8)0
New Permanent Pacemaker2 (4.9)***0
Bioprosthetic Valve Dysfunction or SVD00
Aortic Valve Reoperations / Reintervention00
Acute Kidney Injury (AKI)00
Major Paravalvular Leak (moderate or severe)00

 

EFS Study, Presented at EuroPCR 2024. FIH Study, Presented at EuroPCR 2024.

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.

Hear the Latest Clinical Insights

New York Valves 2024 Symposium

Watch leading experts in the field of TAVR discuss the biomimetic design of the DurAVR® THV and its impact on hemodynamics and blood flow dynamics, presented by Drs Christopher Meduri, Susheel Kodali, João Cavalcante, Michael Reardon, Nicolas Van Mieghem, Azeem Latib, Anita Asgar and Vinayak Bapat.

EuroPCR 2024 Physician Panel Interview

Hear the discussion from Drs Nicolas Van Mieghem, Christopher Meduri, and Azeem Latib on the biomimetic design of the DurAVR® THV and its impact on hemodynamics and blood flow dynamics.

TCT 2023 Physician Panel Interview

Watch this physician panel and hear Drs Michael Reardon, Rebecca Hahn, Christopher Meduri, and Azeem Latib discuss the design of the DurAVR® THV and its impact on hemodynamics.

Publications

EuroIntervention

Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve (DurAVR®)

Read the first-in-human (FIH), prospective, non-randomised, single-arm, single-center study of patients with severe, symptomatic aortic stenosis implanted with the DurAVR® biomimetic transcatheter heart valve. 

 

Authors: Kodali, S., Sorajja, P., Meduri, C. et al. Published: July 2023

Read the full publication
Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve (DurAVR®)

Nature Reviews Cardiology

Restoration of flow in the aorta: a novel therapeutic target in aortic valve intervention

In this Perspective article, the authors review the evidence for the link between aortic flow-related abnormalities and cardiovascular disease and how these changes in aortic fow patterns are emerging as a therapeutic target for aortic valve intervention in first-in-human studies.

 

Authors: Garg, P., Markl, M., Sathananthan, J. et al. Published: October 2023

Read the full publication
Restoration of flow in the aorta: a novel therapeutic target in aortic valve intervention