MRI-safe pacing system garners FDA approval

Boston Scientific announced FDA approval of a new pacing system deemed safe for use in an MRI environment, according to a press release.

The new approval covers the ImageReady MR-Conditional Pacing System, which includes Accolade MRI and Essentio MRI pacemakers, as well as the Ingevity pacing leads. The system is designed to treat bradycardia. Patients implanted with the ImageReady system are able to receive full-body MRI scans in 1.5 Tesla environments, according to the release.

The Ingevity MRI pacing leads, which include active and passive fixation models, are the first passive fixation pacing leads approved in the United States for patients undergoing MRI. The system also features automatic daily monitoring with the wireless LATITUDE NXT system, which provides physicians with device and patient information through customizable alerts, according to the release.

Approval of the ImageReady system and the Ingevity MRI leads followed results of two global clinical trials. The prospective, randomized SAMURAL trial enrolled 351 patients and evaluated the ImageReady system in patients with single- or dual-chamber pacemakers when used in an MRI environment. The prospective, nonrandomized INGEVITY trial assessed safety, effectiveness and performance of the leads in 1,036 patients with single- or dual-chamber pacemakers, according to the release.

“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," Ronald D. Berger, MD, PhD, principal investigator of the SAMURAI trial and professor of medicine and biomedical engineering at Johns Hopkins Medical Institutions, stated in the release. "The study demonstrated the Ingevity MRI leads had no MR-related complications and very low rates of complications overall."

Disclosure: Berger reports financial relationships with Boston Scientific.