FDA approves non-surgical heart valve to treat patients with certain types of congenital heart disease


Sumary of FDA approves non-surgical heart valve to treat patients with certain types of congenital heart disease:

  • Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs..
  • The device is designed for patients who have severe pulmonary valve regurgitation (blood leaking backward into the right lower chamber of the heart), a condition that often results from congenital heart disease..
  • The device, called the Harmony Transcatheter Pulmonary Valve (TPV) System, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care..
  • It can also potentially reduce the total number of open-heart surgeries required over an individual’s lifetime..
  • The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease..
  • 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.”.
  • Bram Zuckerman, M.D., Director, Office of Cardiovascular Devices, FDA’s Center for Devices and Radiological Health Congenital heart defects (CHDs) are conditions that are present at birth and can affect the structure of a baby’s heart and the way it works..
  • After having one of these procedures, the patient may or may not have a working pulmonary valve, which could lead to pulmonary regurgitation..
  • Severe pulmonary valve regurgitation may be corrected through open-heart surgery to place a right ventricle-pulmonary artery conduit or an artificial valve..
  • During the implantation procedure of a Harmony valve, a thin, hollow tube (catheter) with a collapsed Harmony valve on the end is inserted through a vein in the groin or in the neck and into the right side of the heart, and then into the RVOT where it is placed into position..
  • Once the new valve is in place, it opens and closes like a door to force the blood to flow in the correct direction..
  • The primary effectiveness endpoint was percentage of patients with no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at six months….

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