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Three new devices approved to treat bradycardia
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Boston Scientific announced FDA approval and market launch for three new pacemakers designed for the treatment of patients with bradycardia.
The Advantio and Ingenio pacemakers feature RightRate pacing technology designed to treat chronotropic incompetence, which affects up to 42% of pacemaker patients. RightRate employs Boston Scientific’s minute ventilation sensor to restore chronotropic competence, and adds programming options to promote ease of use and in-clinic time savings. In addition, the Ingenio pacemaker offers Respiratory Rate Trend to monitor respiration. Also approved, the Invive cardiac resynchronization therapy pacemaker offers Respiratory Rate Trend as part of HF Perspectiv, a comprehensive suite of HF diagnostics designed to provide health care professionals with additional information to guide treatment decisions, according to information in a company press release.
Bruce L. Wilkoff
The devices are designed for use with Boston Scientific’s new Latitude NXT Remote Patient Management System, which is designed to enable physicians to remotely follow-up on specific pacemaker information and heart health status of patients with these devices. The system detects clinical events between scheduled visits and sends relevant data directly to a secure physician-accessible website via landline or cellular-based telephone technology using AT&T’s wireless network. The system is currently under review by the FDA.
The first implant of the Ingenio pacemaker in the United States was performed on May 3 by Bruce L. Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic, according to the release.
“Matching the patient’s need to increase their heart rate with their precise activities is the main goal of cardiac pacing,” Wilkoff, who also serves as president of the Heart Rhythm Society and a member of the Cardiology Today Editorial Board, stated in the release. “Achieving that match depends on having the right tools, such as an MV sensor and intelligent programming.”
In April, the company announced CE Mark approval and European market launch of the new devices.