CE Mark For Boston Sci’s MRI Compatible Pacemakers

In short

Boston Scientific Corporation has received CE Mark approval for use of its MRI compatible INGENIO™ and ADVANTIO™ pacemakers.

Background

According to estimates, 75% of patients with some form of implantable rhythm device are likely to require MRI scans at some point in their life as part of diagnostic regimes, so having an implanted device which is compatible with MRI is clearly an advantage.

We’ve covered a few pacemakers and ICDs which are compatible with an MRI environment recently with offerings from Biotronik and St.Jude. Non-compatible pacemakers are restricted from undergoing MRI procedures as magnets may interfere with pacemaker functionality, or cause heating of the lead. With Image Ready technology, Boston says its INGENIO MRI pacemakers, in combination with FINELINE™ II leads, allow patients to undergo MRI procedures as needed.

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.

Clinician comments

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

Company comments

“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.”

Remote monitoring capability

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 Boston’s wireless weight scale and blood pressure monitor.

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.

Source: Boston Scientific Corporation