Boston Sci Catching Up in Race for MRI Compatible Devices

The Marlborough, MA-based medical device giant on Monday announced FDA approval of a suite of cardio devices deemed safe to use in an MRI environment.

Qmed Staff

Boston Scientific has some good news when it comes to catching up with its competitors and offering more MRI-compatible cardio devices.

The company on Monday announced FDA approval of a suite of devices that can be used in MRI environments: the ImageReady MR-conditional pacing system, which includes Accolade MRI and Essentio MRI pacemakers; as well as the company's new Ingevity MRI pacing leads. The system is meant to to treat bradycardia, a condition in which the heart beats too slowly, and can be used in 1.5 T environments.

The family of Ingevity leads approved for use with MRI includes both active and passive fixation models. This is the first time a passive fixation pacing lead has been approved for use with U.S. patients undergoing MR scans, according to Boston Sci. 

Approval of the Ingevity leads came after a prospective, non-randomized Ingevity study that enrolled 1,036 patients and a prospective, randomized Samurai trial that enrolled 351 patients. 

"As shown in the Samurai trial, the ImageReady system gives physicians reassurance that they are implanting pacemakers that are safe in an MRI environment should their patients need scans in the future," said Ronald Berger, MD, PhD, principal investigator of the Samurai trial and professor of medicine and biomedical engineering at Johns Hopkins Medical Institutions.

On top of the MRI compatibility the ImageReady system also includes automatic daily monitoring that provides physicians with device and patient information through customizable alerts.

"We believe that the daily monitoring capability of the ImageReady system, coupled with advanced diagnostics, will help physicians identify concerns and ultimately initiate patient care sooner," said Kenneth Stein, MD, chief medical officer for Rhythm Management at Boston Scientific.

The new approvals should provide a boost for Boston Sci, which along with St. Jude Medical has been seeking to catch up to Medtonic when it comes to having MRI-compatible cardiovascular devices approved on the U.S. market. The increased competition appears to have been one of the factors behind Boston Scientific's pacemaker and defibrillator sales declining about $100 million, to $1.8 billion, in 2015. 

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

Like what you're reading? Subscribe to our daily e-newsletter.