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Clinical Evidence

Paradigm-shifting Hemodynamic Performance

 

DurAVR® THV has demonstrated paradigm-shifting hemodynamic results, measured by Effective Orifice Area (EOA), Mean Pressure Gradient (MPG) and Doppler Velocity Index (DVI), sustained to 1 year in small annuli.

 

Mean Annulus Diameter: 22.6 mm

Early Feasibility Study and First‐In‐Human Data (1 Year)

Puri R. Oral Presentation at: Sydney Valves; March 2025; Sydney, Australia.

DurAVR® THV has demonstrated restoration of physiologic flow dynamics

When compared to a healthy aortic valve using cardiac MRI, DurAVR® THV showed no significant difference in flow. In addition, baseline 4D cardiac MRI from the DurAVR® THV EFS study shows turbulent flow with helical and vortical flow patterns, while imagery taken 6 months post-DurAVR® THV implantation shows evidence of healthy laminar flow through the valve and into the ascending aorta. Cardiac MRI is considered the gold standard for assessing and quantifying valve flow dynamics.

 

Normal Valve Flow vs DurAVR Flow
FD = Flow Displacement
FRR = Flow Reversal Ratio

FIH Study, Presented at New York Valves 2024.

 

EFS Study, Presented at New York Valves 2024.

DurAVR® THV has demonstrated a restorative effect on Left Ventricular Mass

Patients treated with DurAVR® THV have experienced significant left ventricular (LV) mass regression, measured on cardiac MRI. Matched analysis also confirmed that the LV mass after treatment with DurAVR® THV was comparable to levels seen in healthy controls. A higher LV mass prior to TAVR has been associated with higher death and rehospitalization five years post-procedure.1 Likewise, LV mass regression one year after TAVR has been associated with lower death and hospitalization rates to five years post-procedure.2

 

LV Mass Pre- and Post-DurAVR® THV
 

LV Mass Pre- and Post-DurAVR THV

LV Mass 
(g)

LV Mass Post-DurAVR® THV Matched to Healthy Controls
 

LV Mass Healthy vs DurAVR

LV Mass 
(g)

 

FIH Study, Presented at TCT 2024

DurAVR® THV Met Targeted Safety Endpoints

High implant success with a good safety profile was demonstrated.

 

Values are n (%)
*Not all DurAVR subjects reached 1 year follow up. Rates were calculated to the longest follow up available.
**Mortality related to car accident (1), sepsis of non cardiac origin (2)
***Endocarditis result in valve explant
EFS & FIH Safety Data
(n=65)		30 Day
1 Year*
All-cause Mortality**0%4.6%
CV Mortality0%0
Disabling Stroke0%1.5%
Endocarditis***0%1.5%
Permanent Pacemaker7.7%9.2%
Coronary Obstruction0%0%
Acute Kidney Injury stage 2/30%0%
Cardiovascular Hospitalizations3.1%6.2%

Puri R. Oral Presentation at: Sydney Valves; March 2025; Sydney, Australia.

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.

 

 

Zero Prosthesis Patient Mismatch (PPM) in Small Annuli

Zero Prosthesis Patient Mismatch (PPM) in Small Annuli

Measured at 1-year, n=37

Low Paravalvular Leak

Low Paravalvular Leak

No moderate or severe PVL

 

 

Puri R. Oral Presentation at: Sydney Valves; March 2025; Sydney, Australia.

Hear the Latest Clinical Insights

TCT 2024 Physician Panel Interview

Drs. Amar Krishnaswamy, Nicolas Van Mieghem, and Bernard Prendergast review the latest DurAVR® THV MRI flow & LV mass data compared to a healthy control group, exploring the impact of valve design on laminar flow, disease regression, and patient outcomes.

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.

Publications

Frontiers in Cardiovascular Medicine

The importance of tissue science and valve design in relation to durability and hemodynamics of the DurAVR aortic heart valve

In this review article, the authors examine the clinical evidence with DurAVR® THV and the tissue and valve design features that contributed to these promising results. 

 

Authors: Neethling WML, Forster G, Meduri C, Meuris B, Asgar AW, Sellers S, Cavalcante JL, Bapat V, Reardon M. Published: Feb 2025

Read the full publication
The importance of tissue science and valve design in relation to durability and hemodynamics of the DurAVR aortic heart valve

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. Feldt K, Cavalcante JL, Garg P, Hamid N, Poon KK, Settergren M, Burns MR, Rück A, Sathananthan J, Zajarias A, Shaburishvil Ti, Zirakashvili T, Zhividze M, Katchakhidze G, Bapat V. 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, Sellers SL, Meduri C, Cavalcante J. Published: October 2023

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

References

  1. Gonzales H, Douglas PS, Pibarot P, et al. Left Ventricular Hypertrophy and Clinical Outcomes Over 5 Years After TAVR: An Analysis of the PARTNER Trials and Registries. JACC Cardiovasc Interv. 2020;13(11):1329-1339. doi:10.1016/j. jcin.2020.03.011
  2. Chau K, Douglas P, Pibarot P, et al. Regression of left ventricular mass after transcatheter aortic valve replacement: The PARTNER trials and registries. JACC. 2020;75(19): 2446–2458. doi:10.1016/j.jacc.2020.03.042