The Trifecta gets its name from three “leaflets” made from heart tissue that are attached to the exterior of the valve’s stent, a flexible mesh tube made of titanium that’s used to prop open blood vessels, according to a statement from the company. The aortic valve controls blood flow from the heart to the rest of the body.
The valve’s stent and leaflets are covered with heart tissue to allow tissue-to-tissue contact when the leaflets open and close, which reduces the amount of wear and deterioration.
St. Jude said the Trifecta’s launch further expands its portfolio of valves available to European patients.
“The Trifecta valve marks an important milestone for St. Jude Medical, and it reflects our commitment to developing products which improve physician control, reduce patient risk and improve patient outcomes,” said Frank Callaghan, president of St. Jude’s cardiovascular division.
Rick Wise, an analyst at Leerink Swann, described the news as “an incremental positive” for the company in an email to investors, writing that St. Jude’s entry into the pericardial aortic segment of the tissue valve market opens up a $450 million opportunity.
Wise wrote that he expects some revenues from the EU launch to trickle in before the end of the company’s second quarter and said officials are looking to push ahead on plans to get the Trifecta through the Food & Drug Administration during the third quarter, with a stateside launch soon after.