Healthcare Industry News: Millennium
News Release - May 6, 2009
St. Jude Medical Announces FDA Clearance and Launch of the Attune Annuloplasty Ring for Heart Valve RepairAdjustable repair ring enables a more individualized repair
ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced the U.S. launch of its Attune(TM) Flexible Adjustable Annuloplasty Ring for the repair of diseased heart valves. The company received U.S. Food and Drug Administration clearance and will introduce the product at the annual meeting of the American Association for Thoracic Surgery in Boston, on May 9.
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 (flaps that open and shut) 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.
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.
“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.
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 five percent each year as the age of the population increases.
“By offering a comprehensive portfolio of valve repair products and introducing a new level of adjustability in our latest offering, St. Jude Medical is providing physicians options that allow them greater control in performing procedures and achieving excellent patient outcomes,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “We continue to invest in cardiac surgery technology to better assist physicians in the treatment of the entire spectrum of heart valve disease, including repair products, a comprehensive offering of gold-standard mechanical valves and durable stented tissue valves.”
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit www.sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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