New Approval for Boston Scientific—Europe Sets the Pace for FDA

Yesterday we told you that Boston Scientific (NYSE: BSX) had got its new family of advanced pacemakers approved for sale in Europe, but that these were not available in the United States. Well, that has changed overnight. Today the Natick, MA, medical device company announced that the FDA have followed in the footsteps of the European regulators and approved the new pacemakers, called Altrua.

The new pacemakers are designed for patients whose hearts beats to slowly, often less than 60 beats per minute. The devices are programmable, so that they can be tailored to each patient’s individual needs and they also have a new “blended sensor” technology that adjusts the heart’s rhythm to different situations. “That is really the biggest difference between us and our competitors,” says company spokesperson Dave Knutson.

“Think of when you are buying groceries. When you come out of the store, carrying the grocery bags, you will probably move more slowly but still need more energy. The blended sensor is unique in sensing the need to kick up the heart rhythm a notch in these situations.”

The global market for pacemakers is around $4 billion, half of it in the U.S., according to Boston Scientific.

Erik Mellgren is a Swedish journalist who worked for Xconomy Boston in 2008 as part of the Stanford Innovation Journalism Fellowship program. His real job is with Ny Teknik, a leading technology and innovation magazine in Sweden, but he loved seeing the Red Sox at Fenway. Follow @

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