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 Called the silent killer, high blood pressure
affects as many as one in three American adults, and medical device
makers were racing to develop a procedure to treat it before the
failure of Medtronic's major clinical trial.
Boston Scientific is still forging ahead with plans to develop its
own blood-pressure-lowering device, called a renal denervation
system, for sale in the United States, Mahoney said in an interview.
Renal denervation devices create tiny scars along nerves in the
kidneys, which play a pivotal role in regulating blood pressure by
sending signals to the brain that can cause blood vessels to
constrict.
The procedure currently is intended as an alternative to drug
therapy for patients whose blood pressure is not well controlled by
traditional medications.
Boston Scientific will examine data from Medtronic's halted study,
in which the company's device failed to prove effective, as it
designs the U.S. clinical trial for its own product, Mahoney said.
"Right now it's going to be a slower market until BSC or another
company delivers on a trial. When that happens, the market will open
up, and it has the potential to be a multibillion-dollar market,"
he said.
Medtronic had a jump-start on the U.S. market in the development of
a treatment, but the failure of its Symplicity device in the study,
announced in January, caught many observers by surprise.
Less than two weeks later, Covidien Plc said it would stop making
its hypertension device, which was approved for sale in Europe in
February 2012, due to weak demand.
Mahoney said repercussions from Medtronic's failed U.S. study will
be felt in Europe, where cardiologists will be less inclined to
recommend the treatment until more evidence of its effectiveness can
be demonstrated in more clinical trials.
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Medtronic continues to sell its device there, and Boston
Scientific in December launched its own offering. St. Jude Medical
Inc is also rolling out a hypertension device in Europe.
But Boston Scientific remains optimistic about the technology's
potential to help the millions of people struggling to control their
blood pressure, Mahoney said.
High blood pressure increases the risk for heart disease and stroke
but often has no symptoms.
"There's clearly a huge patient unmet need," he said.
Mahoney said Boston Scientific's device has features that
differentiate it from Medtronic's product, making it more
consistent, faster to use and less painful for the patient. "We do
feel the platform we have is a superior platform," he said.
Medtronic has said it will form an independent panel of medical
experts to make recommendations on the future of its renal
denervation product.
Boston Scientific acquired its renal denervation system through the
purchase of Vessix Vascular Inc in November 2012.
(Reporting by Susan Kelly in Chicago)
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