Ingenio and Advantio pacemakers receive CE mark approval for use in patients requiring MRI scans


Boston Scientific has received CE mark approval for its Ingenio and Advantio pacemakers for 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 John Bayliss, consultant cardiologist, Watford General Hospital, London; in Italy by Massimo Santini, director of Cardiology Department, San Filippo Neri, Roma; and in Germany by Joern Schmitt, Oberarzt der Justus-Liebig Universitätsklinik Gießen.

Many patients with pacemakers are restricted from undergoing MRI procedures as magnets may interfere with pacemaker functionality, or cause heating of the lead. With the Image Ready technology, Ingenio MRI pacemakers, in combination with Fineline 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 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. According to a company release, 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% of pacemaker patients.