Aortic Heart Valve Received FDA Approval

Edwards Lifesciences Corp. has received approval from the U.S. Food and Drug Administration (FDA) for the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, designed for easier implantation in the heart. 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," says 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.

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"Edwards' new offerings are designed to give cardiac surgeons additional choices in tailoring procedures based on their preferred surgical approach and the needs of their patients," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy.

edwards.com