FDA Approves First in the World Device To Treat Patients wit
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The valve is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation and is called Harmony Transcatheter Pulmonary Valve (TPV) System. The U.S. Food and Drug Administration approved the valve for use in pediatric and adult patients. The valve is the first in the world non-surgical heart valve to treat patients with a native or surgically repaired right ventricular outflow tract.

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. The valve is then released from the catheter; it expands on its own, and anchors to the RVOT. 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 through a prospective, non-randomized, multi-center clinical study. During the study, physicians implanted the device in a total 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. Among patients with evaluable echocardiography data, 89.2% of them achieved the primary effectiveness endpoint.

Adverse events observed during the clinical study included irregular or abnormal heart rhythms, leakage around the valve, minor bleeding, narrowing of the pulmonary valve, and movement of the implant. It is contraindicated for patients with an infection in the heart or elsewhere; patients who cannot tolerate blood-thinning medicines; or patients who have sensitivity to Nitinol.

Source:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-world-device-treat-patients-congenital-heart-disease
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