Technology | Cardiac Resynchronization Therapy Devices (CRT) | November 15, 2016

Medtronic Receives FDA Approval for Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator

Device becomes first CRT-D in U.S. to help improve therapy delivery in heart failure patients using effective pacing

Medtronic, Claria MRI Quad CRT-D SureScan, FDA approval

November 15, 2016 — Medtronic plc  has received U.S. Food and Drug Administration (FDA) approval for the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The Claria MRI CRT-D is approved for scanning in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines, and features EffectivCRT, a new algorithm that automatically tailors the therapy to individual patients by adjusting pacing rates.

"Until now, CRT devices have shown only whether a pacing pulse was sent, but we haven't been able to determine if that stimulation actually improves the heart's pumping ability," said Suneet Mittal, M.D., director, electrophysiology laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, N.J. "With the Claria device, physicians are now able to verify the effectiveness of left ventricular pacing, which is especially beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat because this irregular and rapid heartbeat often interferes with the delivery of effective CRT."

A large percentage of heart failure patients receiving cardiac resynchronization therapy have atrial fibrillation (AF),1 which can significantly reduce patient response to CRT. The Claria device includes the Medtronic-exclusive EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during AF, without adversely affecting the average heart rate.

Additional features on the Claria device include:

  • The AdaptivCRT algorithm, which reduces a patient's odds of a 30-day heart failure readmission by 59 percent,2 and has demonstrated a 46 percent reduction in AF risk compared to echo-optimized biventricular pacing;3
  • VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes,4 and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient;
  • Attain Perfoma MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce phrenic nerve stimulation occurrence,5 steroid on all electrodes, and three shapes for varying patient anatomies; and
  • SureScan MR-conditional labeling for full-body scans without positioning restrictions. Medtronic now offers MR-conditional pacemakers, implantable cardioverter defibrillators (ICDs), insertable cardiac monitors (ICMs) and CRT-Ds. Additionally, patients with certain existing defibrillation leads will be eligible for an MR-conditional ICD or CRT-D, and thus able to access this important imaging technology.

Medtronic also has submitted a Pre-Market Application (PMA) to the FDA for Multiple Point Pacing, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds.

For more information: www.medtronic.com

References

1 Kloosterman M, Maass AH, Rienstra M, Van Gelder IC. Atrial fibrillation during cardiac resynchronization therapy. Card Electrophysiol Clin. December 2015;7(4):735-748.
2 Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.
3 Martin D, et al. Clinical outcomes with adaptive cardiac resynchronization therapy: Long-term outcomes of the Adaptive CRT Trial. HFSA Annual Scientific Meeting. September 23, 2013.
4 Demmer, W. VectorExpress performance results. Medtronic data on file. January 2013.
5 Biffi et al. Effort of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: An acute canine study. Circulation Arrhythmia and Electrophysiology. 2012.

Related Content

Medtronic AdaptivCRT Feature Associated with Improved Heart Failure Patient Survival
News | Cardiac Resynchronization Therapy Devices (CRT) | May 22, 2018
Medtronic plc announced study results showing its AdaptivCRT algorithm is associated with improved patient survival....
Medtronic Recalls CRT-Ds and ICDs Due to Manufacturing Error Preventing Electrical Shock Delivery
News | Cardiac Resynchronization Therapy Devices (CRT) | February 26, 2018
The U.S. Food and Drug Administration (FDA) announced that Medtronic is recalling certain implantable cardioverter...
Abbott Announces MR-Conditional Labeling for Quadra Assura CRT-D and Fortify Assura ICD
Technology | Cardiac Resynchronization Therapy Devices (CRT) | January 03, 2018
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT) | August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT) | July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Videos | Cardiac Resynchronization Therapy Devices (CRT) | May 23, 2017
This video, provided by ERB, demonstrates the function and implantation of the WiSE CRT (Wireless Stimulation Endocar
Biotronik Announces FDA Approval of MultiPole Pacing
Technology | Cardiac Resynchronization Therapy Devices (CRT) | May 11, 2017
May 11, 2017 — Biotronik announced U.S.
Biotronik Launches First FDA-Approved CRM Devices with MRI AutoDetect Technology
Technology | Cardiac Resynchronization Therapy Devices (CRT) | May 10, 2017
Biotronik announced the availability of the first U.S. Food and Drug Administration (FDA)-approved cardiac rhythm...
Overlay Init