FDA Clears New Boston Scientific Devices to Treat Bradycardia

Advanced Pacemaker Platform Treats Chronotropic Incompetence, Which Affects Up to 42 Percent of Pacemaker Patients


May 9, 2012

May 9, 2012 — Boston Scientific Corp. announced U.S. Food and Drug Administration (FDA) approval and market launch of its Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers (CRT-P). The first implant of the Ingenio pacemaker in the United States was performed May 3 by Bruce L. Wilkoff, M.D., director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic.

The Ingenio and Advantio pacemakers feature RightRate pacing technology designed to treat chronotropic incompetence (CI). CI is the inability of the heart to regulate its rate appropriately in response to physical activity, which may cause patients to feel tired or short of breath during daily activities such as walking or climbing stairs. RightRate employs Boston Scientific’s minute ventilation (MV) sensor, the only sensor clinically proven to restore chronotropic competence, and adds programming options to promote ease of use and in-clinic timesavings.

“Matching the patient’s need to increase their heart rate with their precise activities is the main goal of cardiac pacing,” said Wilkoff, who also serves as president of the Heart Rhythm Society, and has authored numerous articles on chronotropic response and rate adaptive pacing. “Achieving that match depends on having the right tools such as an MV sensor and intelligent programming.”

In addition to RightRate, the Ingenio pacemaker offers Respiratory Rate Trend (RRT), an exclusive feature that monitors respiration. The Invive CRT-P offers RRT as part of HF Perspectiv  – a comprehensive suite of heart failure diagnostics designed to provide healthcare professionals with additional information to guide treatment decisions.

“We are very pleased to receive FDA approval for these advanced devices, and excited about the potential they bring to our bradycardia business. With these products, Boston Scientific embarks on a new era in pacing technology,” said Joe Fitzgerald, senior vice president and president of the Boston Scientific cardiac rhythm management group. “The company’s significant investments in the Ingenio platform have been focused on long-term innovation in pacing technologies, and are expected to support a comprehensive series of launches over the next several years to expand our pacing capabilities and help improve patient outcomes.”

The Ingenio, Advantio and Invive devices are designed for use with Boston Scientific’s new Latitude NXT Remote Patient Management system, which is currently under review by the FDA, and will enable physicians to conduct remote follow-ups of device patients to monitor specific pacemaker information and heart health status. The system is designed to detect clinical events between scheduled visits and send relevant data directly to a secure physician-accessible website via landline or cellular-based telephone technology using AT&T’s wireless network, under an agreement between Boston Scientific and AT&T. 

In April, the company announced CE Mark approval and European market launch of the Ingenio and Advantio pacemakers and Invive CRT-P. 

For more information: www.bostonscientific.com