Healthcare Industry News: neuromodulation
News Release - November 26, 2007
St. Jude Medical Announces FDA Approval of Epic Stented Tissue Valve with Anti-Calcification TechnologyST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of its Epic™ Stented Tissue Valve with Linx™ AC Technology. Identical in design to the company’s Biocor™ Valve, which currently leads the tissue valve industry in U.S. market share growth, the Epic Valve also incorporates patented anti-calcification technology designed to protect against tissue mineralization, or hardening.
An estimated 100,000 Americans undergo heart valve replacement annually and the majority of them receive tissue valves.
“The Epic Valve sets a new standard for addressing tissue mineralization and potentially extending long-term valve durability,” said Vibhu Kshettry, M.D., director of Cardiac Surgery at the Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, and a principal investigator in the Epic clinical study. “Enhanced durability, combined with a design that facilitates the implant procedure, makes the Epic Valve an ideal prosthesis.”
When physicians choose tissue valves for patients, durability is a key consideration. Valve durability is affected by both mechanical stress and tissue calcification. The Epic Valve is designed to address both issues to deliver long-term performance. A recently published paper concluded that, over 17 years, the Biocor design reduced tissue fatigue from mechanical stresses. In addition, the Biocor Valve has more than 20 years of clinical experience.
Like the company’s Biocor Valve with the FlexFit™ Stent, the Epic Valve features the industry’s lowest overall valve height, enhancing implantability. In the mitral position, the valve’s low profile reduces the risk of obstructing blood flow into the aorta. In the aortic position, it may provide optimal coronary ostia clearance and reduce the risk of aortic wall protrusion. The new valve will be available in aortic, aortic supra and mitral models.
The Epic Valve was approved following a clinical study conducted under an FDA Investigational Device Exemption. The study evaluated the valve’s safety and efficacy as measured by hemodynamics (the ability to handle blood flow), patient ability to perform everyday activities as measured by the New York Heart Association (NYHA) functional classification system and adverse effects. The study included 762 patients at 19 U.S. sites and three Canadian sites.
St. Jude Medical will roll out the Epic Valve beginning in early 2008.
“The Epic Valve has been rapidly adopted by cardiac surgeons in Europe since its introduction seven years ago. We are confident its U.S. launch will further demonstrate our commitment to advancing the durability, implantability and hemodynamic performance of tissue valves to benefit patients and physicians,” said George J. Fazio, president of St. Jude Medical’s Cardiovascular Division. “The Epic Valve represents a major addition to our U.S. portfolio of cardiac surgery technologies and therapies, which include tissue and mechanical heart valves, valve repair technologies and devices for cardiac ablation.”
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. 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 Company’s Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). 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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