Corvia Medical has secured CE certification for its Corvia Atrial Shunt System under the European Union’s updated Medical Device Regulation (EU MDR 2017/745).
The Corvia Atrial Shunt System is a catheter-based cardiac implant aimed at managing heart failure symptoms by reducing pressures within the heart and lungs.
With millions of people worldwide affected by heart failure, more than half experience a specific condition known as heart failure with preserved ejection fraction (HFpEF). This condition, which leads to significant physical limitations, remains challenging to treat with existing medical interventions.
The device operates by creating a controlled shunt between the left and right atria to lower elevated left atrial pressure, a key factor in the progression of heart failure symptoms.
Corvia Medical is currently conducting RESPONDER-HF, a global clinical trial designed to confirm the safety and efficacy of the device in a targeted patient group. Approximately 70 study sites are participating in the trial, which focuses on patients without latent pulmonary vascular disease or pacemakers.
Earlier studies have indicated that this group derives notable clinical benefits from the atrial shunt procedure.
Founded in 2009 and headquartered in Tewksbury, Massachusetts, Corvia Medical specialises in the development of transcatheter cardiovascular devices.
The Corvia Atrial Shunt previously received breakthrough device designation from the US Food and Drug Administration in 2019, highlighting its potential role in addressing a critical need within the cardiovascular field.
The company operates as a private entity, supported by investments from Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic partner.
Corvia Medical also recently announced three-year results from its REDUCE LAP-HF II clinical trial. This study, involving 626 patients, is the first Phase III trial globally to evaluate an atrial shunt for heart failure management.
Findings confirmed the safety and long-term efficacy of the device in patients with preserved or mildly reduced ejection fraction, specifically those without pulmonary vascular disease or rhythm management devices. This subgroup represented approximately half of the trial participants and demonstrated consistent clinical improvement.
