Technology | March 03, 2014

Medtronic SureScan Approved for Full Body Scans Without Positioning Restrictions

Medtronic SureSan EP Lab Pacemaker MRI Systems Pacing Revo Advisa

March 3, 2014 — The Medtronic SureScan pacing systems are now approved for MRI scans positioned on any region of the body. The U.S. Food and Drug Administration (FDA) previously approved the SureScan for use with magnetic resonance imaging (MRI). Patients implanted with the Advisa DR MRI or Revo MRI SureScan pacing systems now can have MRI scans without positioning restrictions, including the chest area, which was previously restricted. 

Until the availability of Medtronic’s SureScan pacemakers, U.S. patients had been contraindicated from receiving MRI scans due to potential interactions between the MRI and device function. According to published literature, up to 75 percent of patients worldwide with implanted cardiac devices are estimated to need an MRI scan during the lifetime of their devices. 

The approval was made following the FDA review of computer modeling and clinical data confirming that MRI chest-positioned scans are safe for patients. A MR-Conditional pacemaker, the Medtronic Revo MRI was FDA approved in February 2011, and the second-generation Advisa MRI was approved by the FDA in January 2013.

For more information: www.medtronic.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