FDA OKs Boston Scientific's New Line of Pacemakers
U.S. officials gave the green light Monday to Boston Scientific’s (NYSE:BSX) new line of pacemakers used to treat bradycardia, a condition in which the heart beats too slowly.
The drug giant received the OK by the Food and Drug Administration to start marketing the Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers.
The first U.S. Ingenio implant took place on May 3 by a doctor at a clinic in Cleveland. The devices all received marketing approval in Europe last month.
Bradycardia is a condition usually associated with a heart that beats fewer than 60 times a minute, depriving the body of oxygen. Boston Scientific’s devices feature RightRate pacing technology designed to treat chronotropic incompetence, or the inability of the heart to regulate its rate and appropriately respond to physical activity.
That often leads to shortness of breath during daily activities, such as climbing stairs or walking, Boston Scientific said.
“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, who performed the first Ingenio implant and directs cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic. "Achieving that match depends on having the right tools such as an MV sensor and intelligent programming."
The Ingenio device also offers a feature that helps monitor respiration.
President of Boston Scientific’s cardiac rhythm management group called the three new FDA-approved devices the start of a “new era in pacing technology.”
The devices are designed for use with a remote patient management system currently under review by the FDA. The Boston Scientific device would help physicians conduct remote follow-ups and monitor pacemaker information and heart health status.