Boston Sci’s INGENIO and ADVANTIO Pacers Cleared in EU for Use Under MRI

Boston Sci’s INGENIO and ADVANTIO Pacers Cleared in EU for Use Under MRI

PARIS (July 27, 2012) — Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for use of its INGENIO™ and ADVANTIO™ pacemakers in patients in need of a magnetic resonance imaging (MRI) scan. Now equipped with new Image Ready™ technology, the first European implants of the INGENIO MRI pacemaker are being performed in the United Kingdom by Dr. John Bayliss, Consultant Cardiologist at Watford General Hospital, London, in Italy by Prof. Massimo Santini, Director of Cardiology Department, San Filippo Neri, Roma, and in Germany by Dr. Joern Schmitt, Oberarzt der Justus-Liebig Universitätsklinik Gießen.

Pacemakers are designed to treat bradycardia, a condition in which the heart beats too slowly, depriving the body of sufficient oxygen. Many patients with pacemakers are restricted from undergoing MRI procedures as magnets may interfere with pacemaker functionality, or cause heating of the lead. With Image Ready technology, INGENIO MRI pacemakers, in combination with FINELINETM II leads, allow patients to undergo MRI procedures as needed.

“A significant number of patients with pacemakers may be affected by other conditions, which often require MRI scanning,” said Prof. Santini. “The ability for these patients to undergo detection of other conditions is an important advancement in improving overall patient health and outcomes.”

FINELINE II pacing leads are backward MRI compatible and therefore replacement of the lead is not required when implanting the new INGENIO MRI or ADVANTIO MRI pacemakers. More than one million FINELINE II leads have to date been implanted worldwide.

The INGENIO and ADVANTIO pacemakers were first approved in Europe in April 2012. Featuring RightRate™ pacing technology, the devices are designed to treat chronotropic incompetence, a form of bradycardia in which the heart is unable to regulate its rate appropriately in response to physical activity. Chronotropic incompetence affects up to 42 percent of pacemaker patients.

“The ability to use the INGENIO platform during MRI procedures is a significant advancement to our family of bradycardia devices,” said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific. “This progression in the use of the INGENIO family of pacemakers represents another step in our commitment to expanding our pacing capabilities and improving the lives of patients.”

The INGENIO family of pacemakers is compatible with the new LATITUDE™ NXT Remote Patient Management system, which enables physicians to conduct remote follow-ups 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. LATITUDE NXT is also compatible with the wireless weight scale and blood pressure monitor from Boston Scientific. Physicians can choose to remotely monitor a series of relevant health status indicators including weight and blood pressure, as well as respiratory and sleep apnea trending. Centers across Europe are currently enrolling patients in the LATITUDE NXT program.

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About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer, and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit:

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Boston Scientific received FDA approval and is releasing in the U.S. the INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P).

The devices are indicated for treatment of bradycardia, and the INGENIO and ADVANTIO pacemakers specifically feature BostonSci’s RightRate technology for addressing chronotropic incompetence, a condition in which the heart is unable to regulate its rate appropriately in response to physiologic stress, such as an exercise.

More from the announcement:

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 time savings.

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

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 these 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.

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