Boston Scientific implants first US patient in MR Conditional pacing system trial

16 April 2013 (Last Updated April 16th, 2013 18:30)

Medical device manufacturer Boston Scientific has implanted the first US patient in a prospective, open-label, two-group randomised, multi-centre study of its MR Conditional pacing system.

Medical device manufacturer Boston Scientific has implanted the first US patient in a prospective, open-label, two-group randomised, multi-centre study of its MR Conditional pacing system.

The ImageReady pacing system, which was implanted at OhioHealth's Riverside Methodist Hospital in Columbus, Ohio, US, features the company's Ingenio magnetic resonance imaging (MRI) pacemaker family and the new Ingevity MRI pacing leads.

Designed to function in the MRI environment, the Ingevity pacing leads provide key enhancements in handling and fixation compared with standard leads.

Johns Hopkins Medical Institutions medicine professor Ronald Berger said the availability of a pacing system designed to allow patients with pacemakers to undergo a broad set of MRI scanning conditions would advance the quality of patient care.

“The Ingenio MRI pacemaker family also offers pacing technologies not previously available in devices designed for the MRI environment."

"The Ingenio MRI pacemaker family also offers pacing technologies not previously available in devices designed for the MRI environment," Berger said.

Technologies include RightRate rate adaptive pacing with the Minute Ventilation sensor designed to restore chronotropic competence, and RYTHMIQ for minimising unnecessary RV pacing without clinically significant pauses.

Other technologies such as LATITUDE NXT is designed to minimise clinic and patient burden with wireless remote follow-up.

The study, SAMURAI, will enrol 363 patients at 45 centres in seven countries to assess safety and effectiveness of the system in the MRI environment.

The company said it would use the study data to support the US Food and Drug Administration regulatory approval.

Boston Scientific said the MR Conditional pacing system was under clinical investigation and not currently available for sale in the US.