Healthcare Professionals
A Foundation of Clinical Evidence
The Corvia Atrial Shunt is the most clinically studied atrial shunt for the reduction of Left Atrial Pressure (LAP) in heart failure patients with EF≥40%.
Nearly 1,000 patients have been studied to date through multiple studies around the world. Clinical results have consistently established the safety of the Corvia Atrial Shunt System and have demonstrated encouraging efficacy in heart failure patients with an EF≥40% and elevated left atrial pressure.1-2
>600
Corvia Atrial Shunts
implanted globally
>2000
Implanted patient-years of follow-up3
9+
Years post-implant for the longest ongoing Corvia Atrial Shunt patients3
30+
Peer-reviewed publications
on the Corvia Atrial Shunt performance & mechanism of action
2-Year Responder Group Highlights
From REDUCE LAP-HF II1
REDUCE LAP-HF II is the largest device therapy trial for heart failure patients with EF≥40%, the biggest unmet need in cardiology. It defined a specific demographic of heart failure patients who responded positively to atrial shunt therapy, termed “Responders”. Long-term data demonstrate Responders experienced significantly fewer HF events and an improved quality of life compared to sham at 2 years.
REDUCED HF EVENTS
50%
Reduction in HF event rate compared to sham control at two years.
IMPROVED QUALITY OF LIFE
46%
Greater improvement in KCCQ-OSS compared to sham control at two years.
EXCELLENT EASE OF USE & SAFETY
PROCEDURAL SUCCESS
Successful shunt implantation when transseptal puncture is performed for shunt placement3
PATENCY
Flow detected with no echocardiographic evidence of thrombus through two years of follow-up
KEY SAFETY OUTCOMES
| Events in Responders Through 2 Years | Corvia Atrial Shunt (N=161) | Sham Control (N=152) | p-value |
|---|---|---|---|
| Cardiovascular mortality | 1.9% | 1.4% | 0.72 |
| Non-fatal ischemic stroke | 1.9% | 0.0% | — |
| New or worsening kidney dysfunction | 8.8% | 14.9% | 0.10 |
| Major adverse cardiac events | 3.8% | 2.7% | 0.61 |
| ≥30% Decrease in TAPSE | 3.1% | 2.7% | 0.83 |
HEAR FROM THE EXPERTS
Global experts Prof. Maja Cikes and Prof. Finn Gustafsson share insights and their perspectives on the 2-year results from the REDUCE LAP-HF II trial.
ECHOCARDIOGRAPHIC EVIDENCE OF LEFT HEART UNLOADING2
New 2-year echocardiographic data from REDUCE LAP-HF II provides evidence of the favorable long-term effect of atrial shunting on heart structure and function, and support the definition of Corvia Atrial Shunt “Responders”. The analysis showed that the Corvia Atrial Shunt led to reverse remodeling of the left heart chambers and increases in volume of the right heart chambers, without compromising right ventricle systolic function compared to sham.
| CONCLUSION | ECHOGRAPHIC EVIDENCE |
|---|---|
 Shunt is unloading left heart | Decreased LA/LV volume vs sham Decreased LA pressure vs sham Decreased mitral regurgitation grade vs sham |
 Shunt is not negatively affecting right heart | No difference in PASP vs sham No difference in RA systolic pressure vs sham No difference in RV systolic function vs sham |
 Blood flow through shunt from LA to RA | Increased RA volume vs sham Increased RV end-diastolic volume vs sham |
- Gustafsson, F, Petrie, M, Komtebedde, J. et al. 2-Year Outcomes of an Atrial Shunt Device in HFpEF/HFmrEF: Results From REDUCE LAP-HF II. J Am Coll Cardiol HF. 1 Jun 2024. https://doi.org/10.1016/j.jchf.2024.04.011
- Patel, R., et al. “Atrial Shunt Device Effects on Cardiac Structure and Function in Heart Failure With Preserved Ejection Fraction: The REDUCE LAP-HF II Randomized Clinical Trial.” JAMA Card. (2024)
- Unpublished data of June 1, 2024 compiled from Corvia Clinical Trials and on file at Corvia Medical.
- Statistical analyses conducted by Baim Institute for Clinical Research. Data on file.
- Incidence rate ratio (IRR) at 1- and 2-years = 0.49 [95% CI: 0.25-0.95], p=0.034