Transcatheter pulmonary valve for treating failed prosthetic valves approved

The demand for minimally invasive procedures is high and every other company is working hard to make this a reality. And now, the Melody Transcatheter Pulmonary Valve of Medtronic has gained a Food and Drug Administration grant for using it in patients whose formerly implanted pulmonary valve has failed.

As time passes, the surgical valve may deteriorate and thus, the patient would be likely to undergo one more valve replacement, which means another open-heart surgery. With an intention to extend the duration between patient’s open-heart surgeries with a malfunctioned right ventricular outflow tract duct as a result of congenital heart disease, the Melody Transcatheter Pulmonary Valve may now offer these patients with a treatment choice that is minimally invasive, thus preventing other open-heart surgery. This can be a major advantage for already frail patients.

Previously, the device had received premarket approval on the basis of gathered data from 3 clinical trials that involved 310 who were patients implanted with the device, namely, the Melody European & Canadian Post-Market Surveillance Study, the Melody U.S. Post-Approval Study, and the Melody U.S. IDE Study. The data revealed a strong valve functioning in all 3 trials in patients implanted with the device as around 98% of patients were free from open-heart surgery at 1-year post-implant.

Jeremy Asnes said, “Becoming the first commercially accessible transcatheter heart valve, the device has brought an innovative non-surgical alternative for treating the failed pulmonary valve conduits. So many congenital patients across the globe have gained an advantage from this treatment. With this extended intervention, we can decrease the requirement of obtrusive open-heart surgery and more patients can get benefit from this minimum invasive therapy option.”

During the process, the Melody Transcatheter Pulmonary Valve is implanted inside a failing pulmonic surgical heart valve via the lately rolled out Ensemble II Delivery System exclusively developed to deliver the device.

Medtronic, already, has given the world many devices that assist better diagnosis and treatment of patients. And we hope the development goes on successfully with time. Don’t you think this device will be of great assistance to patients?