Boston Scientific landed FDA approval for its ImageReady pacing system that includes the ACCOLADE MRI AND ESSENTIO MRI pacemakers and the INGEVITY MRI leads. As the names imply, the devices are safe for use within an MRI scanner (up to 1.5 Tesla) as long as certain precautions are taken.
The INGEVITY MRI leads are available in either active or passive fixation models, allowing the surgeon to decide whether to screw into the cardiac tissue or to choose pressure-based fixation.
The pacemakers themselves are wireless-enabled, allowing them to automatically report to the cardiologist via the LATITUDE NXT patient management system. The data includes unusual events and can help spot previously unnoticed conditions, leading to earlier therapy.
A few details about the study that led to the approval:
The INGEVITY trial, a prospective, non-randomized study, enrolled 1,036 patients and assessed safety, performance and effectiveness of the leads in patients with a single or dual chamber pacemaker. The SAMURAI trial, a prospective, randomized study, enrolled 351 patients and evaluated safety and effectiveness of the ImageReady System for use in patients with a single or dual chamber pacemaker when used in an MRI environment.
“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 D. Berger, M.D., Ph.D., principal investigator of the SAMURAI trial and professor of medicine and biomedical engineering at Johns Hopkins Medical Institutions. “The study demonstrated the INGEVITY MRI leads had no MR-related complications and very low rates of complications overall.”