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FDA approves St. Jude’s new aortic replacement valve

The company said that the Trifecta valve is designed to optimize the flow of blood through the valve and for long-term durability.

St.Paul-based St. Jude Medical announced Wednesday that the Food & Drug Administration has approved a new pericardial aortic stented tissue valve — the Trifecta.

In a statement, the company said that the Trifecta valve is designed to optimize the flow of blood through the valve and for long-term durability. To ensure the structural integrity of the valve, the Trifecta valve is made from a polyester and tissue-covered titanium stent, or base. The valve has leaflets manufactured from bovine and porcine pericardial tissue which are attached to the exterior of the valve stent. St. Jude believes this design allows the leaflets to open more fully and efficiently, mimicking the performance of a healthy aortic heart valve and limiting tissue abrasion through stent-to-leaflet contact.

“Physicians around the world have already voiced tremendous excitement and satisfaction with the Trifecta valve,’ said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division, in a statement.

St. Jude’s announcement comes the same day the company announced its first quarter results. The company had revenue of $1.38 billion in the quarter ended April 2, up 9 percent compared with the $1.26 billion in the first quarter of 2010. However, profit dropped slightly to $233.4 million, from $238.6 million in the same period a year ago. The company took a charge of $19 million, or $0.06 per share, primarily related to what the company described as “AGA Medical integration expenses associated with contract termination costs in international locations.”

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St. Jude’s Trifecta valve is part of the company’s cardiovascular division, which performed well in the quarter. Total cardiovascular sales were $327 million for the first quarter of 2011, a 28 percent increase over the first quarter of 2010. AGA Medical is part of this group since its acquisition in November.

St. Jude Medical, a manufacturer of new innovative medical devices, also benefited from Boston Scientific suspending ICD sales in the United States.

“We estimate that this dynamic benefited our first quarter 2010 U.S. ICD sales by approximately $25 million,” said St. Jude CFO John Heinmiller in the conference call. “If we adjust to reflect this one-time benefit, our first quarter 2011 sales were up approximately 10 percent on a constant currency basis.”