Heart valve hope for frail US patients
Source: Agencies |
July 19, 2011, Tuesday
|
Print Edition
Print Edition
THE first artificial heart valve designed to be implanted without major surgery appears to help patients too frail to undergo chest-opening surgery, according to US health reviewers.
The Food and Drug Administration posted its review yesterday of a highly anticipated heart valve from Edwards Lifesciences that can be threaded into place through one of the body's major arteries. Cardiologists hope this approach could offer a new option for patients who are not healthy enough to undergo the more invasive open-heart surgery.
FDA says 20 percent more patients who received Edwards' valve were living after one year than patients who received traditional medical care. However, scientists also said patients receiving the device had higher rates of stroke and bleeding in the brain.
The agency will ask heart doctors to weigh in on these risks at a meeting tomorrow, though the agency is not required to follow the group's advice.
Edwards will eventually seek FDA approval to market its valve for patients healthy enough for open-heart surgery. But because the valve is an experimental therapy, it was initially studied for patients with no other options.
Some 300,000 Americans have a diseased aortic heart valve, forcing the heart to work harder to squeeze blood through. Eventually, the condition can lead to heart failure, blood clots and sudden death. More than 50,000 people a year undergo open-heart surgery to replace the valve, and thousands more are turned away, deemed too old or ill to survive the operation.
Edwards' Sapien transcatheter valve, which is already available in Europe, is threaded through a leg artery up to the heart and then propped open and wedged into the aortic opening.
The Food and Drug Administration posted its review yesterday of a highly anticipated heart valve from Edwards Lifesciences that can be threaded into place through one of the body's major arteries. Cardiologists hope this approach could offer a new option for patients who are not healthy enough to undergo the more invasive open-heart surgery.
FDA says 20 percent more patients who received Edwards' valve were living after one year than patients who received traditional medical care. However, scientists also said patients receiving the device had higher rates of stroke and bleeding in the brain.
The agency will ask heart doctors to weigh in on these risks at a meeting tomorrow, though the agency is not required to follow the group's advice.
Edwards will eventually seek FDA approval to market its valve for patients healthy enough for open-heart surgery. But because the valve is an experimental therapy, it was initially studied for patients with no other options.
Some 300,000 Americans have a diseased aortic heart valve, forcing the heart to work harder to squeeze blood through. Eventually, the condition can lead to heart failure, blood clots and sudden death. More than 50,000 people a year undergo open-heart surgery to replace the valve, and thousands more are turned away, deemed too old or ill to survive the operation.
Edwards' Sapien transcatheter valve, which is already available in Europe, is threaded through a leg artery up to the heart and then propped open and wedged into the aortic opening.
- About Us
- |
- Terms of Use
- |
-
RSS - |
- Privacy Policy
- |
- Contact Us
- |
- Shanghai Call Center: 962288
- |
- Tip-off hotline: 52920043
- 沪ICP证：沪ICP备05050403号-1
- |
- 互联网新闻信息服务许可证：31120180004
- |
- 网络视听许可证：0909346
- |
- 广播电视节目制作许可证：沪字第354号
- |
- 增值电信业务经营许可证：沪B2-20120012
Copyright © 1999- Shanghai Daily. All rights reserved.Preferably viewed with Internet Explorer 8 or newer browsers.
