New pacemakers from Boston Sci get FDA's OK

Boston Scientific Corp. on Monday announced U.S. Food and Drug Administration approval and commercial launch of a new generation of pacemakers, including models that regulate the heart rate in response to physical activity.

Called RightRate, the technology uses a sensor to monitor patients with a condition known as chronotropic incompetence. The condition may cause people to feel tired when walking or climbing stairs.

An estimated 42 percent of pacemaker patients suffer from chronotropic incompetence, according to Boston Scientific.

Analyst Rick Wise of Leerink Swann called the approvals "encouraging" news for Boston Scientific and "a good thing to have in your pocket as you walk into the biggest (heart rhythm) meetings of the year."

The Heart Rhythm Society is meeting this week, and Wise said FDA approval of Boston Scientific's new generation of pacemakers has a chance to help the company gain some market share.

The devices, Boston Scientific's first new pacemakers in a decade, are called the Ingenio and Advantio pacemakers and the Invive cardiac resynchronization therapy pacemakers. The first Ingenio pacemaker was implanted Thursday at Cleveland Clinic.

In April, the Natick, Mass.-based company announced European approval and launch of the three devices. Boston Scientific employs about 5,000 people in Minnesota.

"Matching the patient's need to increase their heart rate with their precise activities is the main goal of cardiac pacing," said Dr. Bruce Wilkoff of the Cleveland Clinic, who also serves as the President of the Heart Rhythm Society and has written about chronotropic response and rate adaptive pacing.

In addition to RightRate, the Ingenio pacemaker offers respiratory rate trend, a feature that monitors respiration -- a key vital sign.

The Invive CRT-P also monitors respiration.

The new devices are designed to work in concert with Boston Scientific's new Latitude NXT remote patient management system, which is under review by the FDA.

Latitude enables doctors to remotely monitor pacemaker information and patient heart health, Boston Scientific said. The system detects problems between scheduled visits and can send data directly to a secure website by telephone or cellular phone.