FDA approval includes ACCOLADE™ MRI and ESSENTIO™ MRI pacemakers and INGEVITY™ MRI pacing leads
Boston Scientific Corp has received U.S. FDA approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady™ MR-Conditional Pacing System, which includes ACCOLADE™ MRI and ESSENTIO™ MRI pacemakers, as well as the new INGEVITY™ MRI pacing leads, is designed to treat bradycardia, a condition in which the heart beats too slowly. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met.
The newly-approved family of INGEVITY MRI pacing leads includes active and passive fixation models. This marks the first time a passive fixation pacing lead is approved for U.S. patients undergoing MR scans.
Approval of the INGEVITY MRI leads, as well as the full ImageReady System, was based on data from two global clinical trials. 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."
The ImageReady System offers automatic daily monitoring via the LATITUDE™ NXT Patient Management System. An increasingly important tool for physicians, automatic daily monitoring has been shown to improve survival in patients with pacemakers1. The LATITUDE NXT wireless system allows for earlier intervention and improved patient outcomes by providing physicians with device and patient information through customizable alerts.
"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," said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. "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."
The company is also actively pursuing MRI compatibility for their currently approved implanted cardiac defibrillation (ICD) and cardiac resynchronization therapy (CRT) systems via the global ENABLE MRI study, which was initiated earlier this year. Trial findings will be submitted to regulatory agencies in Asia and the U.S., when the company requests updated labeling for MR-conditional use on ICD and CRT systems, including those that have been previously implanted.
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1 Varma N, Piccini JP, Snell J, Fischer A, Dalal N, Mittal S. "The Relationship Between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients." J Am Coll Cardiol. 2015 Jun 23; 65(24):2601-10.