Boston Scientific (NYSE:BSX) said yesterday that it won FDA approval for its ImageReady line of MR-conditional pacemakers, including the Accolade MRI and Essentio MRI pacers and the Ingevity MRI leads.
Marlborough, Mass.-based Boston Scientific, which won CE Mark approval in the European Union for the Ingevity leads in March 2014, said the approval covers for full-body, 1.5 Tesla MRI scans for patients implanted with the full ImageReady system, including active and passive fixation models.
“With a pacing system specifically designed with automatic remote monitoring that also allows patients to undergo MR scans, we are further advancing the quality of patient care,” rhythm management chief medical officer Dr. Kenneth Stein said in prepared remarks. “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.”
“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,” added principal investigator Dr. Ronald Berger of Baltimore’s Johns Hopkins Medical Institutions. “The study demonstrated the Ingevity MRI leads had no MR-related complications and very low rates of complications overall.”
Boston Scientific said it’s also pursuing MRI compatibility for the implantable cardiac defibrillators and cardiac resynchronization therapy devices it already has on the market, with the Enable MRI study it launched earlier this year.
