FDA Clears St. Jude Medical’s Attune Annuloplasty Ring for Heart Valve Repair
May 7, 2009 - St. Jude Medical Inc. today started the U.S. launch of its Attune Flexible Adjustable Annuloplasty Ring for the repair of diseased heart valves.
The company received FDA clearance and will introduce the product at the annual meeting of the American Association for Thoracic Surgery May 9 in Boston.
The Attune ring is a flexible annuloplasty ring designed to support a repair of the heart’s mitral valve. The ring’s flexibility allows the annulus to continue its natural movement as the valve opens and closes, thus contributing to more physiologic valve function. The ability to adjust the ring post-implant promotes ideal leaflet alignment to reduce or eliminate residual regurgitation, or small leaks after the repair.
Unlike most other flexible annuloplasty rings that have a fixed size, the Attune ring can be adjusted after it is sutured to the annulus – a feature that allows physicians greater control in altering its size and shape to contribute to a more refined repair specific to fit each patient’s heart valve anatomy. The Attune ring is suitable for repairs performed with open chest, minimally invasive or robotic surgical approaches, St. Jude said.
“The surgeon’s goal in mitral valve repair is to restore the natural function of the valve. The thin, flexible Attune ring allows the normal physiologic changes in annular shape to be preserved. The adjustability is designed to allow the surgeon to fine tune the annular diameter to optimize leaflet apposition and help ensure a successful repair,” said John A. Spratt, M.D., cardiothoracic surgeon at Roper Hospital, Charleston, S.C.
The mitral valve controls the flow of oxygenated blood between the upper and lower chambers of the heart. When a mitral valve malfunctions due to infection, heart attack damage, a congenital condition or other cause, the valve no longer closes tightly because its leaflets become misaligned, allowing blood to regurgitate, or leak backward. Without treatment, a leaky heart valve can lead to irregular heartbeat, clotting, stroke and heart failure. Cardiac surgeons use a variety of techniques to restore proper leaflet closing and alignment, including annuloplasty: implanting a ring around the circular base of the valve to support the repair.
Guidelines issued in 2006 by the American Heart Association and the American College of Cardiology encourage heart valve repair over replacement when possible, and recommend repair earlier in the valvular disease process. An estimated 37,600 Americans underwent heart valve repair in 2008, according to Millennium Research Group. This number is projected to increase approximately 5 percent each year as the age of the population increases.
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