Boston Scientific Receives FDA Approval For MR-Conditional Pacing System

Boston Scientific has received U.S. Food and Drug Administration (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.

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.

A press release can be found from Boston Scientific webstie following this link.