Boston Scientific’s Ingenio pacemaker wins FDA approval

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

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-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.

The Ingenio system is key to an “increasingly compelling product pipeline” expected to boost sales starting in 2013, said Rick Wise, a Leerink Swann & Co. analyst in New York, in an investor note. The early approval, given before the Heart Rhythm Society meets this week in Boston, will help the company spread the word about the entries into a $4 billion pacemaker market.


“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.”

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Boston Scientific and competitors have faced slowing sales of defibrillators, used to shock a stopped heart back into a normal rhythm, 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.

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.

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.