Let’s Move the Conversation Forward

Challenge the Conventions

Expand the Focus

Advance the Definition of Success in Aortic Stenosis

Paradigm-shifting Hemodynamic Performance

Now with US EFS results, DurAVR™ THV delivers the promise of optimal Effective Orifice Area (EOA) + Mean Pressure Gradient (MPG) combined with the deliverability performance of a balloon-expandable system

 

Mean Annulus: 22.73mm

FIH Data presented at TCT 2023

DurAVR™ THV First‐In‐Human Data

Meduri C. DurAVR™ Biomimetic Transcatheter Aortic Valve: First In Human Update. Oral presentation at: Transcatheter Cardiovascular Therapeutics (TCT) Conference; October, 2023; San Francisco, CA.

Mean Annulus: 22.2mm

Doppler Velocity Index (DVI): 0.62
(30 day, n=12)

Latib A. DurAVR™ THV: Early Feasibility Study. Oral presentation at: PCR London Valves Conference; November, 2023; London, UK.

Early Feasability Study Data

Latib A. DurAVR™ THV: Early Feasibility Study. Oral presentation at: PCR London Valves Conference; November, 2023; London, UK.

Image for decoration, as a base for a graph item
Image for decoration, as a base for a graph item
Image for decoration, as a base for a graph item

DurAVR™ demonstrated 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)

DurAVR™ met targeted safety endpoints

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

Cardiac Mortality

Myocardial Infarction

Disabling Stroke

Life-threatening Bleeding

n=12

Cardiac Mortality

n=12

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

Myocardial
Infarction

n=12

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

Disabling
Stroke

n=12

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

Life-threatening Bleeding

n=12

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

DurAVR™ THV FIH Study, Presented at TVT 2023.

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.

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 haemodynamics.