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Boston Scientific’s Ingenio Pacemaker Wins U.S. FDA Approval

Boston Scientific Corp.’s Ingenio and Advantio pacemakers won U.S. approval to treat abnormally slow heartbeats, clearing the way for sales of devices that have been in development for a decade in the $4 billion global market.

The pacemakers are designed to help the heart adjust to demands from physical exercise and ease shortness of breath during walking, climbing stairs or other activities. The Natick, Massachusetts-based company said it also gained Food and Drug Administration clearance for the Invive pacemaker, used to help synchronize cardiac contractions in heart failure patients.

Pacemakers haven’t been an area of focus for Boston Scientific in the past, said Rick Wise, a Leerink Swann & Co. analyst in New York, in a telephone interview. The approval builds on other advances the company has made with its defibrillators, used to shock a stopped heart back into a normal rhythm, and will help it gain share in the market for devices to regulate the heart, he said.

“It has a lot of new features that put us squarely even with and, in important respects, ahead of what the competition can offer,” said Ken Stein, chief medical officer for Boston Scientific’s cardiac rhythm management group, by telephone. “We are starting to deliver on the product turnaround and a complete refresh of our product pipeline.”

The approval comes just before the Heart Rhythm Society meeting this week in Boston, giving the company a good opportunity to introduce the devices and educate doctors about their offerings, Wise said.

Defibrillator Sales

Boston Scientific and competitors have faced slowing sales of defibrillators and drug-coated stents that hold open clogged arteries after they’ve been cleared. While pacemaker sales have been stable, newer products such as Medtronic Inc.’s Revo MRI SureScan pacing system that is safe with advanced imaging procedures have captured additional market share.

Boston Scientific rose 1.9 percent to $6.31 at the close of New York trading. The shares have fallen 18 percent in the past 12 months.

The Ingenio and Invive devices monitor respiratory rate in addition to the heartbeat, providing doctors with information on an early warning signal for a weakening heart, Stein said. Breathing rates typically rise, even when patients are resting, as their hearts falter and they have trouble getting oxygen, he said. The respiration rate is an important vital sign that doctors will be able to track over time, he said.

Latitude NXT

All three devices were designed to work with the company’s experimental Latitude NXT Remote Patient Management System. The system uses a wireless connection to take daily reading from patients after they are in bed and send the results to their doctors, adding an additional layer of information and protection to their regular office visits, Stein said.

The Ingenio system was approved based on a Boston Scientific study conducted in Europe, where it was cleared last month. The company is working on a version of the pacemaker that is safe for patients to undergo magnetic resonance imaging without losing any of the functions that help doctors and patients manage the heart, Stein said.

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