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News

Stented tissue valve receives US FDA approval

St Jude Medical : 27 November, 2007  (New Product)
The US Food and Drug Administration (FDA) has given approval of St Jude Medical’s 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 US market share growth, the Epic Valve also incorporates patented anti-calcification technology designed to protect against tissue mineralisation, 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 mineralisation and potentially extending long-term valve durability,' said Vibhu Kshettry, MD, 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 haemodynamics (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 US launch will further demonstrate our commitment to advancing the durability, implantability and haemodynamic 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 US portfolio of cardiac surgery technologies and therapies, which include tissue and mechanical heart valves, valve repair technologies and devices for cardiac ablation.'
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