Medtronic (MDT) Receives FDA Approval of Claria MRI CRT-D SureScan Device

November 14, 2016 9:17 AM EST

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Medtronic (NYSE: MDT) 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(TM), 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(TM) 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(TM) 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(TM) Perfoma(TM) MRI SureScan(TM) 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.
  • SureScan(TM) 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.

"The Claria MRI CRT-D is our latest innovation to help improve patients' response to CRT, establishing a new level of personalized care," said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, and medical director for the Cardiac Rhythm and Heart Failure division of Medtronic. "And it further expands our industry-leading MR-conditional portfolio of devices, which are helping to improve the lives of more patients throughout the world."

In addition to introducing CRT to the worldwide marketplace nearly 20 years ago, and offering the first MR-conditional CRT-defibrillators in the U.S., the Medtronic heart failure portfolio includes mechanical circulatory support therapy and impactful heart failure diagnostics and expert analysis through Medtronic Care Management Services.

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(TM) CRT-Ds. The Multiple Point Pacing feature is not currently approved for commercial sale in the United States.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.



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