CHICAGO, Sept 21 (Reuters) - Nearly two-thirds of high-risk patients who received an Edwards Lifesciences Corp aortic heart valve through a less-invasive procedure were alive two years after the treatment, the company reported on Monday.
The study examined outcomes for 339 patients considered inoperable or at very high risk for traditional open-heart surgery to treat severe aortic stenosis under Canada's compassionate clinical use program.
About half of the patients received an Edwards replacement valve using a transfemoral approach in which the device is threaded to the heart via the femoral artery in the thigh. The other half received the valve through a transapical procedure involving a small incision between the ribs. Survival rates were similar in both groups.
'The Edwards valve was associated with positive acute and midterm results in very high-risk patients across Canada, and our findings illustrate high device success,' said the study's lead author, Dr. Josep Rodes-Cabau, interventional cardiologist at the Quebec Heart & Lung Institute at Laval University and the study's lead author.
The data were presented in San Francisco at the annual Transcatheter Cardiovascular Therapeutics scientific meeting, sponsored by the Cardiovascular Research Foundation.
Also at the meeting, Edwards presented 12-month follow-up data from its 130-person Partner EU clinical trial that showed improvements in the physical and mental well-being of patients who received its Sapien transcatheter valve and gains in physical activity as measured by functional tests.
Irvine, California-based Edwards, the world's largest maker of replacement heart valves, is a pioneer in the development of transcatheter valves that can be implanted without the need for open-heart surgery. The company sells its Sapien valve in Europe and is hoping for approval in the U.S. market by 2011.
(Reporting by Susan Kelly; Editing by Tim Dobbyn) Keywords: EDWARDS/STUDY (susan.kelly@thomsonreuters.com; phone 312 408 8134; Reuters Messaging: susan.kelly.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The study examined outcomes for 339 patients considered inoperable or at very high risk for traditional open-heart surgery to treat severe aortic stenosis under Canada's compassionate clinical use program.
About half of the patients received an Edwards replacement valve using a transfemoral approach in which the device is threaded to the heart via the femoral artery in the thigh. The other half received the valve through a transapical procedure involving a small incision between the ribs. Survival rates were similar in both groups.
'The Edwards valve was associated with positive acute and midterm results in very high-risk patients across Canada, and our findings illustrate high device success,' said the study's lead author, Dr. Josep Rodes-Cabau, interventional cardiologist at the Quebec Heart & Lung Institute at Laval University and the study's lead author.
The data were presented in San Francisco at the annual Transcatheter Cardiovascular Therapeutics scientific meeting, sponsored by the Cardiovascular Research Foundation.
Also at the meeting, Edwards presented 12-month follow-up data from its 130-person Partner EU clinical trial that showed improvements in the physical and mental well-being of patients who received its Sapien transcatheter valve and gains in physical activity as measured by functional tests.
Irvine, California-based Edwards, the world's largest maker of replacement heart valves, is a pioneer in the development of transcatheter valves that can be implanted without the need for open-heart surgery. The company sells its Sapien valve in Europe and is hoping for approval in the U.S. market by 2011.
(Reporting by Susan Kelly; Editing by Tim Dobbyn) Keywords: EDWARDS/STUDY (susan.kelly@thomsonreuters.com; phone 312 408 8134; Reuters Messaging: susan.kelly.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2009 AFX News
