Frequently Asked Questions

What is an investigational medical device?

An investigational medical device is a device that is intended to be used for medical purposes, but does not have approval from the U.S. Food & Drug Administration (FDA) for its clinical indication. The use of the device is the subject of a clinical trial designed to evaluate the safety and/or effectiveness of the device.

What is the purpose of a clinical study?

Clinical studies are research studies that are designed to establish the safety, performance and effectiveness of investigational medical products and procedures. Read more about the REDUCE LAP-HF IV study at www.clinicaltrials.gov.

What is the Corvia® Atrial Shunt?

The Corvia Atrial Shunt is a cardiac implant designed to reduce the pressure in the left side of the heart and lungs. The implant allows blood to flow from the left to the right atrium (the upper chambers of the heart), reducing the pressure in the left atrium, the primary cause of the symptoms of heart failure.

How is the Corvia Atrial Shunt placed?

During a catheter-based procedure, an interventional cardiologist or electrophysiologist inserts a catheter (small tube) in a vein in your groin to access the heart. This catheter is used to create a very small passage in the heart wall between the right and left atria. The doctor places the atrial shunt in the newly created passage to allow blood to flow from the left to the right atrium, decreasing pressure in the left side of the heart and lungs and thereby reducing your heart failure symptoms.

Who can participate?

If you are 40 years or older, have symptoms of heart failure, and meet study criteria, you may be eligible to participate.

Will my insurance cover the Corvia Atrial Shunt procedure?

The Corvia Atrial Shunt System is implanted as part of an FDA authorized clinical trial. Consistent with requirements of the Patient Protection and Affordable Care Act (PPACA), insurers will cover medically necessary patient care costs in clinical trials in the same way they reimburse medically necessary care for members not in clinical trials. Coverage of the Corvia Atrial Shunt procedure itself will vary depending on your individual insurer and your coverage policy. Your medical team will work together with you, the hospital, and your insurer to determine whether the Corvia Atrial Shunt System will be covered by your insurer. They will discuss deductibles, copayments, or other costs, if any, that you or your supplemental coverage plan will be expected to pay.

What company is sponsoring the study?

The clinical study is being sponsored by Corvia Medical, Inc., a US medical device company revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. For more information on the company, visit www.corviamedical.com.