Still for all the good news, the study wasn't a randomized comparison with surgically implanted valve replacements; yet, in spite of that, the study can still show, as Dr. Jones hopes it will, that the device can extend "the useful life of a previously surgically implanted conduit, thereby reducing the total number of open-heart surgeries these patients face over a lifetime."

For the Melody is not designed to be a fire-and-forget, one-time treatment of pulmonary valve defects, but rather to spare children born with the faulty valve as many risky open-heart surgeries as possible. Dr. Jones says that patients born with pulmonary valve defects require operations to switch out replacement valves about once every nine years.


"We expect ultimately, there will be deterioration of even the Melody valve leaflets, or progressive fractures of the Melody valve stent," he says, but he hopes for a useful life that matches or exceeds surgically implanted conduits, and that in any case can be replaced by valves inserted using the less invasive catheter techniques.

"Some design features of the Melody valve are really quite attractive in terms of durability," Dr. Jones says. "The stent that the Melody valve is suspended in keeps the valve in a rounded shape much better than a surgically implanted conduit that doesn't have external support."

"How well that will translate is difficult to say," he adds. "The durability of the device is an area of intense study on our part."

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