Nov 19 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
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.