Nov 19 (Reuters) - St. Jude Medical Inc said on Monday that it had received approval from European health regulators to market its transcatheter aortic heart valve.
The 23mm (0.9-inch) device, called Portico, has received “CE Mark” approval for transfemoral delivery. That means the valve is implanted using a catheter that is threaded through the femoral artery, the main artery in the leg, sparing patients the need for open-heart surgery.
The product was designed for patients with severe aortic stenosis who are considered to be too high-risk for open-heart surgery. This disease keeps the aortic valve from opening fully, decreasing blood flow from the heart.
The St. Jude device would compete in Europe with similar products made by Edwards Lifesciences Corp and Medtronic Inc
St. Jude said it intended to initiate a European study of a 25mm version of the valve to support European approval before the end of the year.
Wells Fargo analyst Larry Biegelsen said the 23mm valve was appropriate for only about 20 percent of patients.
“Approval in Europe for the 23mm valve is unlikely to generate significant revenue,” he wrote in a note to clients. “We estimate Portico revenue of $30 million and $60 million in 2013 and 2014, respectively.”
St. Jude posted 2011 sales of $5.61 billion.
The company’s shares were up 1.4 percent at $35.52 in morning trading on the New York Stock Exchange.