FDA approves world's 1st device to treat congenital heart disease patients

The FDA approved the world's first nonsurgical heart valve device meant to treat patients with severe pulmonary valve regurgitation, which often is a result of congenital heart disease, the agency announced March 26. 

The Harmony Transcatheter Pulmonary Valve System offers a minimally invasive option for pediatric and adult patients with a native or surgically repaired right ventricular outflow tract by improving blood flow to the lungs without open-heart surgery, which is the current standard of care for patients with pulmonary valve regurgitation. 

The device could extend the amount of time before a patient would require open-heart surgery, and may reduce the overall number of open heart surgeries a patient has throughout their lifetime, the FDA said. 

During the procedure, a small catheter with a collapsed Harmony valve is inserted and placed into the RVOT. Once the valve is in place and the catheter is released, the valve opens and closes, directing blood flow in the right direction. 

The FDA evaluated the device's safety and effectiveness in a clinical study involving 70 patients. After six months, 89.2 percent of patients had acceptable heart blood flow and did not require additional surgical or interventional procedures related to the device. All patients had follow-up examinations one month, six months and annually through five years after the implant procedure. The follow-up period has been extended to 10 years as part of a post-approval analysis. 

To learn more, click here. 

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