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Medtronic Receives CE Mark for its Next Generation Cardiac Resynchronization Therapy-Pacemakers

February 24, 2017 By Medtroinc

(Credit: Medtronic)

Medtronic announced that it has received the CE  Mark for their quadripolar cardiac resynchronization therapy pacemakers (CRT-Ps). Theyallow patients to receive MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines. This complete line of CRT-Ps, available in Europe in March, includes the Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan and Solara Quad CRT-P MRI SureScan, and enables proactive heart failure management alongside pacing technology and patient access to the most advanced diagnostic imaging procedures available. 

These devices are not yet approved for sale in the United States.

“Quadripolar devices, such as these new pacemakers, allow more pacing programming options, which allows us to better optimize CRT delivery,” says Dr. Massimo Mantica of Istituto Clinica Sant’Ambrogio, Milano, Italy. “Advanced technology continues to give us smarter devices that enable more personalized treatment for patients.”

The Percepta Quad CRT-P features the EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during atrial fibrillation (AF), without adversely affecting the average heart rate. It also includes VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes,1 and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient.

The Percepta Quad and Serena Quad CRT-Ps also feature the Medtronic-exclusive 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 Both devices also feature Multiple Point Pacing, which can stimulate two sites on the left ventricle (lower chamber) simultaneously or sequentially.

Additional features available in all three devices include:

  • Attain Perfoma MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce phrenic nerve stimulation occurrence,4 steroids on all electrodes, and three shapes for varying patient anatomies.
  • SureScan MR-conditional labeling for full-body scans without positioning restrictions. Medtronic now offers MR-conditional pacemakers, implantable cardioverter defibrillators, insertable cardiac monitors, cardiac resynchronization therapy defibrillators (CRT-Ds) and CRT-Ps.

“With the addition of quadripolar CRT-P devices to our heart failure portfolio, we now offer a comprehensive line of CRT devices to further meet the needs of patients throughout Europe,” says 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. “Our new quadripolar CRT-P devices include advanced, smart technologies that allow physicians to provide each patient with the appropriate therapy specific to his or her individual needs, all while offering access to advanced life-saving MRI technologies.”

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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