Technology | May 11, 2009

Edwards Lifesciences Receives FDA Clearance for New Heart Valve

May 10, 2009 - Edwards Lifesciences Corp. Friday said it received clearance from the FDA for the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, designed for easier implantation in the heart.

The company is introduced the valve, as well as the PORT ACCESS EndoDirect minimally invasive surgery system, at the American Association for Thoracic Surgery's (AATS) 89th Annual Meeting in Boston last week.

The new valve includes a low profile and smooth commissure posts to ease insertion through small incisions or small aortic roots.

"The Magna Ease valve sets a new standard for tissue valves, by combining enhanced implantability with the unsurpassed hemodynamics and long-term durability of bovine pericardial tissue," said cardiac surgeon Michael J. Mack, M.D., founder of CSANT, a cardiology and cardiac surgery practice in Dallas, Texas, and a paid consultant to Edwards Lifesciences.

Also at the AATS annual meeting, Edwards is introducing the PORT ACCESS EndoDirect System, which allows cardiac surgeons to stop a patient's heart and keep it at rest for the duration of the heart valve procedure without an incision down the middle of the chest. In procedures such as mitral valve repair and replacement, the EndoDirect System provides a minimally invasive alternative for direct aortic cannulation when femoral access (groin cannulation) is not an option.

For more information: www.edwards.com

Related Content

Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Scientists Show How Cells React to Injury From Open-Heart Surgery
News | Cardiovascular Surgery | May 04, 2017
Cedars-Sinai Heart Institute investigators have learned how cardiac muscle cells react to a certain type of injury that...
ERACS Session Highlights Need for Standardized Best Practices in Cardiac Surgery
News | Cardiovascular Surgery | May 02, 2017
The recently formed group Enhanced Recovery After Cardiac Surgery (ERACS) hosted an organizing session in Boston on...
Overlay Init