The Natick, Mass.-based med-tech maker said the watchdog agency granted pre-market approval for its Ingenio and Advantio pacemakers and for its Invive cardiac resynchronization therapy pacer.
The first U.S. implant of an Ingenio device happened May 3 at the Cleveland Clinic, according to a press release. That device and the Advantio are designed to treat "chronotropic incompetence" –
the inability to properly regulate heart rate during physical activity. Boston Scientific said the devices use a sensor to measure "minute ventilation," saying it’s "the only sensor clinically proven to restore chronotropic competence." The Ingenio model also measures respiration rate, the company said.
Last month BSX won CE Mark approval for the Ingenio line of devices in the European Union.