News | Cardiac Resynchronization Therapy Devices (CRT) | March 17, 2016

Medtronic Receives CE Mark for MRI-compatible CRT Devices

Company now offers both 1.5 and 3 Tesla indications for MR-conditional CRT-Ds, implantable cardiac monitors, pacemakers and implantable cardioverter defibrillators

Medtronic, CE Mark, MRI compatibility, CRT-Ds, pacemakers, ICDs

Amplia MRI Quad CRT-D SureScan image courtesy of Medtronic


March 17, 2016 — Medtronic plc announced that it received CE (Conformité Européenne) Mark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans.

This full line of CRT-Ds, also labeled for 1.5T scanners, is now available in Europe to help treat heart failure and reduce the risk of sudden cardiac arrest in patients with Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems. All three CRT-Ds are approved for MRI scans without positioning restrictions. The Claria CRT-D is not approved for sale in the United States.

"The ability to provide CRT-D patients with access to MRI scans is a significant, necessary advancement that may help save lives," said Prof. J. Schwitter, cardiologist and director of the Cardiac MR Center at the University Hospital Lausanne, Switzerland. "The most common magnetic field strength for an MRI is 1.5T, particularly for cardiac MRI; however, many institutions are installing 3T scanners to provide increased image clarity for conditions involving the brain and spine. With expanded access to 3T scans, physicians can now use a broader spectrum of MRI machines to most accurately diagnose critical and even life-threatening conditions."

As many as 40 percent of CRT patients will need an MRI within four years after receiving a device. However, until the availability of MR-conditional CRT-Ds, patients with these devices were contraindicated from undergoing MRI scans because of the potential interaction between the MRI and the device function, which could result in risk to the patient. This has prevented thousands of heart failure patients from receiving an MRI scan, an important imaging technology used by doctors to diagnose conditions such as stroke, cancer, Alzheimer's disease, and muscle, bone and joint pain.

The Claria MRI CRT-D features the EffectivCRT Diagnostic and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates, without adversely affecting the average heart rate,  to tailor the therapy to individual patients.

The Claria MRI and Amplia MRI CRT-Ds also feature the AdaptivCRT algorithm, which has been shown to improve CRT response rate by 12 percent and to reduce risk of atrial fibrillation by 46 percent compared to echo-optimized biventricular pacing. They also enable Multiple Point Pacing, which can stimulate two sites on the left ventricle (lower chamber) simultaneously.

Additional features available in all three devices include:

  • Attain Perfoma MRI SureScan Quadripolar Leads: Attain Perfoma left ventricular leads include short bipolar spacing to reduce phrenic nerve stimulation (PNS) occurrence; steroid on all electrodes; and three shapes for varying patient anatomies; and
  • VectorExpress technology: An automated in-office test that reduces lead programming to two minutes and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient.

In addition to the full line of CRT-Ds, Medtronic MR-conditional cardiac rhythm and heart failure devices and leads previously approved for 1.5 Tesla are now approved for full body scans in both 1.5 and 3T MRI machines in Europe. These include: Advisa MRI and Ensura MRI pacemakers, Micra transcatheter pacing system, Reveal XT and Reveal LINQ insertable cardiac monitors (ICMs), and Evera MRI and Visia AF MRI implantable cardioverter defibrillators (ICDs).

For more information: www.medtronic.com


Related Content

News | Cardiac Resynchronization Therapy Devices (CRT)

October 27, 2021 ​​— EBR Systems Inc., developer of the world’s first wireless cardiac pacing system for heart failure ...

Home October 27, 2021
Home
News | Cardiac Resynchronization Therapy Devices (CRT)

August 3, 2021 — In association with Heart Rhythm 2021, Biotronik announced first enrollments in the landmark BIO ...

Home August 03, 2021
Home
News | Cardiac Resynchronization Therapy Devices (CRT)

March 3, 2021 — Medtronic announced new results from the landmark REVERSE trial, evaluating outcomes of cardiac ...

Home March 03, 2021
Home
News | Cardiac Resynchronization Therapy Devices (CRT)

May 13, 2020 — Cardiac resynchronization therapy (CRT) using biventricular pacing (BVP) or His bundle pacing (HBP) is ...

Home May 13, 2020
Home
Feature | Cardiac Resynchronization Therapy Devices (CRT) | Valentina Kutyifa M.D., Ph.D.

Cardiovascular disease is the leading cause of death for women in North America, and women with heart failure often ...

Home March 09, 2020
Home
News | Cardiac Resynchronization Therapy Devices (CRT) | Dave Fornell, Editor

May 15, 2019 — A pilot trial has shown His pacing in cardiac resynchronization therapy (CRT) has been shown to ...

Home May 15, 2019
Home
News | Cardiac Resynchronization Therapy Devices (CRT)

April 29, 2019 — Biotronik announced the full commercial launch of the Acticor device family, including Acticor DX and ...

Home April 29, 2019
Home
News | Cardiac Resynchronization Therapy Devices (CRT)

April 18, 2019 – Biotronik announced the European market release of what it calls the world’s smallest implantable ...

Home April 18, 2019
Home
Technology | Cardiac Resynchronization Therapy Devices (CRT)

March 15, 2019 – Biotronik announced U.S. Food and Drug Administration (FDA) approval of the Acticor and Rivacor high ...

Home March 15, 2019
Home
News | Cardiac Resynchronization Therapy Devices (CRT)

May 22, 2018 — Medtronic plc announced study results showing its AdaptivCRT algorithm is associated with improved ...

Home May 22, 2018
Home
Subscribe Now