Medtronic Launches Unique Annuloplasty Ring for Dynamic Repair of the Heart’s Mitral Valve
CG Future® COMPOSITE Annuloplasty Ring Has Flexible Anterior Segment, Semi-rigid Posterior Segment to “Remodel” the Valve
MINNEAPOLIS – August 16, 2006 – Medtronic, Inc. (NYSE: MDT) today announced worldwide introduction of the new and unique Medtronic CG Future® COMPOSITE Annuloplasty Ring used by heart surgeons to repair – rather than replace – a mitral valve that is narrowed or leaking. The new CG Future COMPOSITE Ring is the industry’s first annuloplasty product providing both semi-rigid posterior remodeling and fully flexible anterior support, thereby allowing physiologic movement throughout the cardiac cycle.
“The CG Future COMPOSITE Ring offers the flexibility of a band and the confidence of a ring,” said Oern Stuge, M.D., president of the Cardiac Surgery business at Medtronic. “This one-of-a-kind product was created with the patient and their implanting surgeon in mind. The composite design offers semi-rigid remodeling of the posterior portion of the mitral annulus with flexibility across the anterior, both of which are important in helping return patients to a normal functioning mitral valve after their surgery.”
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. Weakness, shortness of breath, excessive perspiration and nausea are common symptoms of mitral valve insufficiency, which is sometimes congenital but may also be caused by tissue overgrowth, infection or damage from heart attacks.
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. The new Medtronic CG Future® COMPOSITE Annuloplasty Ring incorporates a flexible anterior segment seamlessly connected to a semi-rigid posterior metal portion. The composite design is engineered to support and hold the rear of the valve in alignment while allowing optimum physiological movement for the front of the valve throughout the cardiac cycle. The radiopaque device’s firm, yet flexible, construction combines with its low bulk, low profile, and innovative anchoring eyelets designed for strength and predictable, time-efficient implantation.
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 31,000 repair procedures would take place this year.1
Revised Guidelines for the Management of Patients With Valvular Heart Disease, published by the American College of Cardiology and the American Heart Association last month, advised that, “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.”2 The guidelines followed publication of earlier studies supporting mitral valve repair in which it was credited for shorter hospital stays and lowered mortality rates. A Mayo Clinic report found that more than 90 percent of patients referred there for mitral valve regurgitation undergo repair instead of replacement and that the success rate was 95 to 99 percent.
Co-developers and initial implanters are Stephen B. Colvin, M.D., and Aubrey C. Galloway, M.D., of NYU Medical Center, New York. They also developed the original CG Future® Annuloplasty Band, which was added to Medtronic’s valve repair product line in 2001. Other Medtronic annuloplasty products include the Duran AnCore® and the Simplici-T™ Annuloplasty Systems.
“Medtronic is gratified to join with Drs. Colvin and Galloway in the incremental improvement and adaptation of devices to extend the safety and effectiveness of valve repair,” Stuge said. “We look forward to continued improvements as valve repair becomes even more prevalent and minimally invasive.”
For total valve replacement, Medtronic offers the Hancock® II tissue valve, the Mosaic® tissue valve, the stentless Freestyle® tissue valve and the Medtronic Hall® mechanical valve.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
1 “U.S. Opportunities in Heart Valve Disease Management,” Report #057-1-US-0705-221, July 2005, p. 3-31
2"ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease,” Journ Am Coll Cardiol, Vol.48, No. 3, p. 107
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