The FDA approved the ImageReady MR-conditional pacing system on April 25 to treat patients with bradycardia.
The system from Boston Scientific includes the Accolade and Essentio pacemakers and the Ingevity MRI pacing leads. The company said patients who are implanted with the system are able to receive full-body MR scans in 1.5 Tesla environments.
The approval of the ImageReady system and the Ingevity leads were based on the prospective, non-randomized Ingevity trial and the prospective, randomized Samurai trial. The Ingevity study assessed the leads in 1,036 patients who had a single or dual chamber pacemaker. The Samurai pacemaker study evaluated the ImageReady system in 351 patients who had a single or dual chamber pacemaker and underwent an MRI.
Patients implanted with the system will have daily monitoring through Boston Scientific’s Latitude NXT patient management system.
Earlier this year, Boston Scientific began enrolling patients in the ENABLE MRI study, which is testing the MRI compatibility of its currently FDA-approved implantable cardiac defibrillation and cardiac resynchronization therapy systems. The company said it would submit results of the study to the FDA and regulatory agencies in Asia.