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Heart Valve Surgery Is Advanced By New Medtronic Repair Device That Uniquely Addresses the Geometry of the Mitral Valve


Profile 3D™ Annuloplasty System to Help Increase Mitral Valve Repair
Today Only 40% of Candidate Patients Receive Valve Repair Instead of Replacement Despite Guidelines and Evidence of Lower Mortality and Shorter Hospital Stays

Medtronic, Inc. (NYSE: MDT) today announced the U.S. launch of the Profile 3D Annuloplasty Ring used by heart surgeons to repair – rather than replace – a failing mitral valve. To promote natural function, the Profile 3D ring design is based on the geometry of the saddle-shaped human mitral annulus. Data strongly suggest that nature conserves the saddle-shaped annulus for a mechanical benefit. Specifically, leaflet stress can be related to saddle height, which could affect long-term durability of the repair.

A three-dimensional annuloplasty ring represents a vital evolution of the science. With designs that replicate natural mitral geometry we would expect to see natural valve dynamics and the potential for increased durability in the repaired heart valve,” said Michael Acker, M.D., chief of the Cardiac Surgery Division of The Hospitals of the University of Pennsylvania,

“We’re seeking to ensure that patients receive the best possible treatment. Mitral valve repair has been found to be superior to valve replacement in the majority of patients but we’re a long way from ensuring that all surgeons have the skills and experience necessary to perform these repairs. A physiologically-designed advance like the Profile 3D Ring holds instinctive appeal for cardiac surgeons, driving interest in mitral repair as an essential skill and ultimately helping ensure that more patients benefit from the most appropriate procedure,” added Dr. Acker.

Early implant sites of the new Profile 3D Annuloplasty Ring include The Hospitals of the University of Pennsylvania, University of Pittsburgh Medical Center, William Beaumont Hospital, and Inova Fairfax Hospital.

When functioning normally, the dome-shaped mitral valve controls blood flow from the lungs, closing tightly under the pressure of freshly oxygenated blood when the heart contracts, then opening when the heart relaxes. Blood then flows into the left ventricle, the heart’s main pumping chamber, where it is pumped throughout the body’s circulatory system with the next heartbeat. Fatigue and shortness of breath are common symptoms of mitral valve insufficiency.

During mitral valve repair, the surgeon seeks to restore, or “remodel” a narrowed, prolapsed or leaking valve to a more-normal shape and leaflet alignment, thus restoring its functionality. Surgeons are increasingly opting to repair damaged or degenerated mitral valves rather than replacing them with prosthetic devices. According to the American Heart Association’s 2006 Statistical Update, 95,000 persons underwent heart valve surgery in U.S. hospitals during 2003. In a July 2005 report, Health Research International estimated the growth of mitral valve repair in the United States at a combined annual growth rate of 8.6 percent and estimated that 36,400 mitral repair procedures would take place this year, accounting for approximately 40% of mitral valve procedures.

Revised Guidelines for the Management of Patients With Valvular Heart Disease, published by the American College of Cardiology and the American Heart Association in 2006, advised, “When possible, (mitral valve) repair is the treatment of choice for degenerative valve disease” because patients whose heart rhythm is normal do not need strong anticoagulant medication, the risk of clots or infection is low, functionality is good, ventricular function is unaffected, and “the long-term survival rate is favorable compared with mitral valve replacement.” The guidelines followed publication of earlier studies supporting mitral valve repair in which it was credited for shorter hospital stays and lowered mortality rates.

Profile 3D joins a comprehensive portfolio of Medtronic annuloplasty products including the CG Future®, Duran AnCore® and the Simplici-T® Annuloplasty Systems. For total valve replacement, Medtronic offers the Hancock® II tissue valves, Mosaic® tissue valves, stentless Freestyle® tissue valve, and the Medtronic Hall® mechanical valve.


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