Healthcare Industry News:  mitral valve 

Devices Cardiology

 News Release - December 16, 2010

St. Jude Medical Launches New Trifecta Valve in Canada

Next-generation pericardial tissue valve provides physicians with an advanced valve, designed for superior hemodynamic performance

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced the Canadian launch of its Trifecta™ aortic stented tissue valve. The first procedures in Canada were performed by Dr. Anson Cheung, Surgical Director of Cardiac Transplantation for Providence Health Care.

The Trifecta valve is a clinically proven replacement valve for patients with diseased, damaged or malfunctioning aortic heart valves. The next-generation tissue valve has a tri-leaflet stented pericardial design, which offers excellent hemodynamic performance.

Commenting on his experience with the Trifecta valve, Dr. Anson Cheung said, "I am very excited to see the introduction of the St. Jude Medical Trifecta valve in Canada. I have been implanting this valve as part of the IDE (investigational device exemption) trial and am very happy with its ease of implant and handling. Also, the hemodynamic performance is superb."

The Trifecta valve is constructed using a polyester and tissue-covered titanium stent, or base, to ensure structural integrity of the valve. Designed to be implanted in the supra-annular aortic position, the valve features leaflets manufactured from pericardial tissue attached to the exterior of the valve stent. This design allows the leaflets to open more fully and efficiently, mimicking the performance of a healthy aortic heart valve, while also mitigating tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact. Additional attributes of the Trifecta valve include proprietary tissue fixation and the St. Jude Medical patented Linx™ AC Technology, an anti-calcification treatment designed to reduce tissue mineralization (hardening), a common complication in previous generations of tissue valves.

“St. Jude Medical has developed a next-generation aortic stented tissue valve that is specifically designed for improved hemodynamic performance, durability and implantability,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “The Trifecta valve has demonstrated outstanding hemodynamic performance, improving the quality of life for patients with diseased aortic heart valves. We look forward to continuing to grow our legacy of market-leading valves with this advanced technology and will continue to put more control in the hands of physicians who treat cardiac patients worldwide.”

The Trifecta valve offers several features that improve the ease of implantation, including the valve’s unique holder, designed to improve visibility and cuff access for suturing, and the valve’s simplified sizing process, offering physicians more control in choosing the appropriate replacement valve for each patient’s heart.

For more than 30 years, St. Jude Medical has demonstrated a commitment to cardiac surgery, offering patients the gold standard in mechanical heart valve performance and tissue valve durability. The Trifecta stented tissue valve further expands the St. Jude Medical valve product portfolio, which includes market-leading mechanical heart valves, valve annuloplasty rings and porcine tissue valves with superior durability for both the aortic and mitral valve.

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 more than 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 sjm.com.

About Providence Health Care

Providence Health Care is one of Canada's largest faith-based health care organizations, operating 15 health care facilities in Greater Vancouver. Guided by the principle "How you want to be treated," PHC's 1,200 physicians, 6,000 staff and 1,500 volunteers deliver compassionate care to patients and residents in British Columbia. Providence’s programs and services span the complete continuum of care and serve people throughout B.C.. PHC operates one of two adult academic health science centres in the province, performs cutting-edge research in more than 30 clinical specialties, and focuses its services on six “populations of emphasis”: cardio-pulmonary risks and illnesses, HIV/AIDS, mental health, renal risks and illness, specialized needs in aging and urban health. For more information on Providence Health Care, please visit our website at http://www.providencehealthcare.org.

Forward-Looking Statements

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 Quarterly Report on Form 10-Q for the fiscal quarter ended October 2, 2010. 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

Issuer of this News Release is solely responsible for its content.
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