Heart-valve specialist Edwards Lifesciences has developed a next-generation replacement aortic valve that can be implanted with a smaller catheter than previous versions, allowing it to fit through narrower, more clogged arteries.
In the photo at right, the older, larger model is shown on top, with its uncovered, unexpanded heart valve visible. The new, narrower catheter is the lower one. Its cover hides the unexpanded valve until it’s ready to be implanted.
Irvine-based Edwards announced today that a doctor in Vancouver, B.C., has successfully implanted three of the new valves in cardiac patients.
The company expects to start a clinical trial of the new valve in Europe later this year, said Larry L. Wood, corporate vice president for transcatheter valve replacement.
Like the company’s catheter-implanted valves that are currently in use in Europe and in clinical trials in the United States, the new valve replaces patients’ failing aortic valves without open-heart surgery. It is mounted on a metal frame that is expanded by a balloon into the old valve opening, simply pushing apart the old valve to make room for the new one. The catheter enters the body through a leg artery and from there is snaked upward through the arterial system to the heart.
For the new valve design, the metal frame is made of a cobalt chromium alloy, a material that is used in coronary stents. The company’s current valve frames are made of stainless steel.
When some final work on the cover assembly are completed, Edwards said, the diameter of the new implant catheters will be about 6 millimeters, or one-quarter of an inch. The diameter of its older catheters is about 7.5 millimeters, or one-third of an inch
The new technology will make valve implants available to an increasing number of patients with brittle, calcified valves, known as stenosis, said Dr. Craig Smith, chief of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center and a leader of the ongoing clinical trial of Edwards heart valves.
“Soon physicians will be able to treat virtually all high-risk aortic stenosis patients with transcatheter valves,” he said.
“We estimate that for every patient who receives an aortic valve replacement, there is another who goes untreated; half of these untreated patients with severe symptoms will die within two years,” he said.
FOR MORE INFOThe O.C. Register video “New heart valve, no heart surgery” shows how Edwards valve are implanted via catheters. For more on Edwards, its heart valves and its Irvine-based competitor CoreValve, see previous coverage here.
This post was updated at 1 p.m. March 5 to improve the description of the catheters in the photo at top.
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