J.P. Morgan analyst Michael Weinstein was hoping to get some more information about St. Jude Medical's
Instead, he was greeted by a simile.
"We are like the duck that looks calm on the surface with the feet pedaling furiously below the surface," said a coy Dan Starks, chief executive of St. Jude Medical.
Renal denervation is used to treat hypertension, or high blood pressure, by the ablation of the nerves that line the renal arteries using a catheter.
In his prepared remarks before taking questions from analysts, Stark described renal denervation as a major new growth market. He added that the company expects European regulatory approval before the end of 2012.
Although he would add little more, the comment reveals that the time line for clearing the regulatory hurdle has moved up. Presentation slides from an investor conference in February show that the company expected European approval in 2013. The company plans to submit an investigational device exemption application to the U.S. Food and Drug Administration next year.
St. Jude believes that about 76.4 million Americans suffer from high blood pressure, and worldwide, the number stands at 1 billion. The annual direct cost to treat this condition globally is $500 billion.
While St. Jude Medical ramps up its efforts in renal denervation, its in-state competitor has recently won FDA clearance to begin enrolling patients in a randomized clinical trial across 60 U.S. medical centers. Medtronic's $800 million-plus acquisition of Ardian brought the Simplicity renal denervation catheter system within its product portfolio and company officials are more than optimistic about the product's potential. The Simplicity system is already available in Australia.
"We view renal denervation for the treatment of uncontrolled hypertension as one of the most exciting growth markets in medical devices," said Sean Salmon, vice president and general manager of the Coronary and Peripheral Business at Medtronic, in a statement that announced the acquisition.
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