Boston Scientific Corp. said it has received U.S. Food and Drug Administration approval for its Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers.
The Natick-based company launched the devices immediately, and the first implant of an Ingenio model in the U.S. was performed May 3 at the Cleveland Clinic.
The Ingenio and Advantio pacemakers are designed to address a condition in which the heart fails to regulate its rate appropriately, resulting in tiredness and shortness of breath during daily activities. The Ingenio pacemaker has an additional feature that monitors respiration, while the Invive offers comprehensive diagnostics around heart failure.
The pacemakers are intended for use with Boston Scientific's new Latitude Remote Patient Management system, which is now under FDA review. The system is designed to monitor patients between doctor's visits and send data on clinical events directly to doctors over landline or wireless networks.
The three new pacemakers received regulatory approval and launched in Europe last month.