St. Jude Medical Wins FDA Approval for Heart Valve
St. Jude Medical on Monday said U.S. regulators approved the sale of a new heart valve with technology designed to protect against hardening of the tissue due to calcification.
The U.S. Food and Drug Administration approved the replacement valve, called Epic, which is based on the company's Biocor valve technology and is expected to be more durable, the St. Paul, Minnesota-based medical device maker said.
St. Jude said it will roll out the Epic valve beginning in early 2008.
St. Jude competes against Edwards Lifesciences Corp in the market for replacement heart valves and has been gaining market share over the past year.
About 100,000 Americans receive heart valve replacements each year, and most get valves made from animal tissue.