Technology | EP Lab | April 28, 2016

Boston Scientific Earns FDA Approval for ImageReady MR-Conditional Pacing System

Approval includes Accolade MRI and Essentio MRI pacemakers and Ingevity MRI pacing leads

Boston Scientific, FDA, ImageReady MR-Conditional Pacing System

April 28, 2016 — 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.

"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 pacemakers. The Latitude NXT wireless system allows for earlier intervention and improved patient outcomes by providing physicians with device and patient information through customizable alerts.

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 United States, when the company requests updated labeling for MR-conditional use on ICD and CRT systems, including those that have been previously implanted.

For more information:www.bostonscientific.com

Related Content

Earlier this year, Medtronic began a worldwide pivotal study evaluating its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system to treat dangerously fast heart rhythms. The EV ICD system is designed to deliver lifesaving defibrillation and pacing therapy via a device the same size as traditional, transvenous ICDs, but with a lead (thin wire) placed outside the heart and veins. The future of CRM device technology.

Earlier this year, Medtronic began a worldwide pivotal study evaluating its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system to treat dangerously fast heart rhythms. The EV ICD system is designed to deliver lifesaving defibrillation and pacing therapy via a device the same size as traditional, transvenous ICDs, but with a lead (thin wire) placed outside the heart and veins.

Feature | EP Lab | November 11, 2019 | Hrishikesh Kadam
Cardiac rhythm management (CRM) devices in use today are evolving to raise the bar beyond monitoring and managing car
A comparison between the EPstar 2F and 6F catheters from Baylis. Electrophysiology catheters. EP lab

A comparison between the EPstar 2F and 6F catheters from Baylis.

News | EP Lab | October 31, 2019
October 31, 2019 — Baylis Medical announced the first North American use of its EPstar Fixed...
New Study Shows Chronic Epilepsy Associated With Marker of Cardiac Electrical Instability
News | EP Lab | October 24, 2019
LivaNova PLC announced the publication of a new study in Neurology, which suggests that chronic epilepsy may be...
Lenox Hill Hospital Opens New Heart Rhythm Center
News | EP Lab | August 27, 2019
Lenox Hill Hospital (New York, N.Y.) has established a brand new Heart Rhythm Center dedicated to the treatment of...
Damaged Hearts Rewired With Nanotube Fibers

Researchers at Texas Heart Institute and Rice University have confirmed that flexible, conductive fibers made of carbon nanotubes can bridge damaged tissue to deliver electrical signals and keep hearts beating despite congestive heart failure or dilated cardiomyopathy or after a heart attack. Image courtesy of Texas Heart Institute.

News | EP Lab | August 15, 2019
Thin, flexible fibers made of carbon nanotubes have now proven able to bridge damaged heart tissues and deliver the...
Cardiac Device Complications Vary Widely Among Hospitals
News | EP Lab | July 31, 2019
The chances of patients experiencing complications after having a cardiac device implanted vary according to where they...
A new infection risk scoring system has been developed based on data from the large PADIT Trial.[1] The new scoring system was presented as a follow up to that study during a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions.

Figure 1: The PADIT infection risk score ranging from 0 to 14 points classified patients into three risk groups, low (0-4), intermediate (5-6) and high (≥7). The risk groups had rates of hospitalization for infection of 0.51%, 1.42% and 3.41%, respectively 

News | EP Lab | May 15, 2019
May 15, 2019 — A new infection risk scoring system has been developed based on data from the large PADIT Trial.[1] Th
Studies Find Race and Gender Disparities in Implantable Heart Devices
News | EP Lab | May 15, 2019
May 15, 2019 - Three new studies show that patients who are medically indicated for implantable heart devices, includ
Overlay Init