New Heart Disease Device Is First of Its Kind

The US Food and Drug Administration (FDA) has approved a new device to help treat a condition tied to congenital heart disease.

The FDA approved the Harmony Transcatheter Pulmonary Valve (TPV) System to treat severe pulmonary valve regurgitation. This condition is often the result of congenital heart disease. It involves blood leaking the wrong way into the lower right heart chamber.

As a nonsurgical valve meant to treat right ventricular outflow tract (RVOT), the Harmony TPV is the first of its kind in the world.

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease," said Dr. Bram Zuckerman, director of the FDA's Office of Cardiovascular Devices, in a press release. "It offers a less-invasive treatment alternative to open-heart surgery to patients with a leaky native or surgically-repaired RVOT and may help patients improve their quality of life and return to their normal activities more quickly, thus fulfilling an unmet clinical need of many patients with congenital heart disease."

The FDA noted that the Harmony TPV may increase the amount of time before a patient needs another open-heart surgery. And it might help reduce the total number of heart surgeries patients need throughout their lives.

To implant the Harmony valve, a medical professional uses a thin tube called a catheter to push the valve through a vein in the neck or groin and into the right side of the heart. From there, the valve expands and settles into place.

The valve then opens and closes in a way that prevents the backflow of blood into the lower right chamber of the heart, the FDA noted.

The FDA approved this device based on the results of a trial of 70 patients who received the valve implant. None of the patients died, and more than 89 percent of patients achieved acceptable heart blood flow by the six-month mark.

Adverse events tied to this device included abnormal heart rhythm, minor bleeding, leaking around the valve and movement of the implant, the FDA noted. Patients who have any kind of infection, who cannot take blood thinners, or who have a sensitivity to nickel or titanium cannot use this device.

If you have any form of heart disease, speak with your doctor about your treatment options.