The U.S. Food and Drug Administration said Friday it approved Medtronic PLC's first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically repaired right ventricular outflow tract, a condition that often results from congenital heart disease.
The device, called the Harmony Transcatheter Pulmonary Valve 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.
The FDA said the use of the Harmony valve may delay the time before a patient needs additional open-heart surgery. It also can potentially reduce the total number of open-heart surgeries required over an individual's lifetime.
During the implantation procedure of a Harmony valve, a thin, hollow tube 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. The valve is then released from the catheter and it expands on its own. 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 FDA assessed the safety and effectiveness of the Harmony TPV device in a study of 70 patients. All patients were scheduled for follow-up examinations at the start of the study, at implant procedure, discharge, and post implant at one month, six months and annually through five years. The follow-up has been extended to 10 years as part of the post-approval study.
The primary safety endpoint was no procedure- or device-related death within 30 days following the implant, which 100% of patients attained. 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. Among patients with evaluable echocardiography data, 89.2% of them achieved the primary effectiveness endpoint.
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