Melody™ Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System, for pediatric patients with right ventricular outflow tract (RVOT) conduit obstructions, has again been tested yesterday at Morgan Stanley Children’s Hospital of NewYork-Presbyterian. This is one of the three centers in the nation where a Medtronic-sponsored feasibility study of the device is being performed. As we reported before, the system has been approved for pediatric use in O’Canada.
The following is from the hospital press release:
Dr. William Hellenbrand leads the study at Morgan Stanley Children’s Hospital of NewYork-Presbyterian, where he is chief of pediatric cardiology and director of the Pediatric Cardiac Catheterization Laboratory. He is also professor of clinical pediatrics at Columbia University College of Physicians and Surgeons.
“This unique and innovative procedure allows us to replace the patient’s heart valve by threading the device through a vein in their leg and into their heart. Previous research has shown that these patients can expect a reduced need for potentially risky open-heart surgery — and therefore improved quality of life,” Dr. Hellenbrand explains.
The TPV device is currently only available in the research context to patients whose implanted valved-conduit has shown signs of narrowing and/or severe leakage. It is estimated that between 500 and 1,000 patients in the U.S. meet this criteria in a given year.
To date, 32 patients have been successfully implanted in the U.S., including 11 at Morgan Stanley Children’s Hospital. In addition, nearly 300 patients have been successfully implanted with the device in Europe and Canada, where it has been approved for widespread use.
And that is probably the crux of the matter. Given the small segment of patient population the system is designed for (quite a sick population, no less!), and given the real need for a minimally invasive PA valve, it’s just a matter of time before the device become available in the US as well. But that is simply our opinion.
New York- Presbyterian Hospital/Columbia University Medical Center press release…
Flashbacks: The Melody™ Valve Approved in Canada; Melody™ Transcatheter Pulmonary Valve