DurAVR™ THV Clinical Evidence

Clinical Evidence

Paradigm-shifting Hemodynamic Performance

Now with US EFS results, DurAVR™ THV delivers outstanding hemodynamic results, measured by Effective Orifice Area (EOA), Mean Pressure Gradient (MPG) and Doppler Velocity Index (DVI).

Mean Annulus: 22.73mm

First‐In‐Human Data (1 Year)

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^TM Transcatheter Heart Valve. 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.

Mean Annulus: 22.2mm 

Early Feasibility Study Data

Meduri C. DurAVR™ biomimetic transcatheter heart valve: early feasibility and first-in-human trial update. Oral presentation at: EuroPCR Conference; May 2024; Paris, France.

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

DurAVR™ Met Targeted Safety Endpoints

High implant success with a good safety profile was demonstrated.
No valve-related adverse events occurred to 1-year follow-up

Values are n (%)
 *Subject had pre-existing significant conduction abnormalities with prolonged QRS
EFS Safety Data	30 Days (n=15)
Primary Safety Endpoints
All-cause Mortality or Disabling Stroke	0
Secondary Safety Endpoints
All-cause Mortality	0
Disabling Stroke	0
VARC-3 Type 2-4 Bleeding	0
Major Vascular or Structural Heart Complications	0
Acute Kidney Injury (AKI) Stage 3 or 4	0
Moderate or Severe Aortic Regurgitation	0
New Permanent Pacemaker	1 (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 Mortality	0	1 (5)*
Myocardial Infarction	0	0
Disabling Stroke	0	0
Life-threatening Bleeding	0	0
Secondary Safety Endpoints
Valve-related Mortality	0	0
All Strokes	1 (2.4)**	0
All Bleeding	2 (4.9)	0
Major Access Site / Vascular Complications	4 (9.8)	0
New Permanent Pacemaker	2 (4.9)***	0
Bioprosthetic Valve Dysfunction or SVD	0	0
Aortic Valve Reoperations/Reintervention	0	0
Acute Kidney Injury (AKI)	0	0
Major Paravalvular Leak (moderate or severe)	0	0

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

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 flow 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