Using a catheter-based insertion, the experimental J-Valve should prevent blood from leaking back into the heart, a condition that can lead to heart failure
SCOTTSDALE, Ariz. — Oct. 19, 2023 — For patients with a condition known as aortic regurgitation, Arizona’s first non-surgical replacement of an aortic valve— the heart’s blood doorway to the body — will be performed today at HonorHealth Research Institute, providing an alternative for those patients who don’t qualify for open-heart surgery.
A proper functioning aortic valve prevents blood from backing up into the left ventricle — the heart’s most powerful chamber — which pumps blood at high pressure, through the aortic artery and ensures oxygen-rich blood flows to the body’s furthest capillaries.
When the aortic valve fails to close tightly, blood leaks backward into the left ventricle with each heartbeat, a relatively common condition known as aortic insufficiency, or aortic regurgitation, which can lead to an enlargement of the heart and heart failure.
Using an experimental J-Valve, today’s procedure will be performed for a Scottsdale woman by David G. Rizik, M.D., medical director of the Research Institute’s Cardiovascular Research Division.
“Our aspiration for this clinical trial is that we will finally develop a safe, effective and durable therapy for the non-surgical, catheter-based treatment of aortic insufficiency,” Dr. Rizik said. “At present, the standard way we treat these patients is with open-heart surgery. Many of these patients may not be candidates for opening their chest cavity, so having a catheter-based alternative treatment is going to be critical for many patients.”
Using a catheter, the J-Valve is delivered through large arteries, through the aorta, and inside the heart. It replaces the patient’s leaky valve at the point where the left ventricle connects to the aorta.
“At present, there is no catheter-based treatment for aortic regurgitation; only surgery,” Dr. Rizik said. “If we can develop a non-surgical, catheter-based technique, we hopefully can treat those patients who are not surgical candidates. What we are trying to prove with this study is that the J-Valve is a durable, safe and effective therapy for this common disease process.”
Today’s patient is the first of three expected to receive the J-Valve at the Research Institute. If successful, this clinical study (J-Valve TF Early Feasibility Study) would lead to a larger clinical trial that could eventually result in FDA approval of the J-Valve and broad commercial use. Patients will be enrolled at the Research Institute no later than Dec. 15. Patients who receive the J-Valve will be monitored for 5 years.
The J-Valve was created by JC Medical Inc., a New York-based company primarily engaged in the design and development of transcatheter valve replacement products for the minimally invasive treatment of structural heart diseases.