BOSTON SCIENTIFIC’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 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 synchronise cardiac contractions in heart failure patients.
Pacemakers havent been an area of focus for Boston Scientific in the past, said Rick Wise, a Leerink Swann and 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.
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. 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.
Boston Scientific and competitors have faced slowing sales of defibrillators and drug-coated stents that hold open clogged arteries after theyve been cleared. While pacemaker sales have been stable, newer products such as Medtronic’s Revo MRI SureScan pacing system that is safe with advanced imaging procedures have captured additional market share.
Boston Scientific rose 1.5 per cent to $6.29 at 10.43am in New York. The shares had fallen 20 percent in the past 12 months before today. 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. – (Bloomberg)
