Study Shows Medtronic's Cardiac Monitor Tops Standard Care for Atrial Fibrillation Detection

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  • Medtronic plc MDT has announced clinical trial results from the STROKE atrial fibrillation (AF) trial assessing its Reveal LINQ Insertable Cardiac Monitor (ICM) to detect abnormal heartbeats compared to standard of care.
  • The findings were published in the Journal of the American Medical Association.
  • The study evaluated 496 patients, including 284 large vessel and 208 small vessel stroke patients.
  • At 12 months, AF was detected in 12.1% of patients in the ICM arm compared to 1.8% in the standard of care arm, equivalent to a greater than seven-fold increase in detecting AF in the ICM arm.
  • 78% of patients who had AF would have been missed if only monitored for 30 days. The median time to detection of AF was 99 days.
  • Rates of AF detection in the ICM arm were similar between patients with index strokes due to small vessel versus large vessel disease (12.6% compared to 11.7%, respectively).
  • At 12 months, 96.3% of first AF episodes were asymptomatic in the ICM arm.
  • The majority (55.5%) of patients with AF detected had an episode lasting more than one hour.
  • Separately, the company received FDA approval for its SenSight directional lead system used in deep brain stimulation (DBS) therapy.
  • The system is designed to combine directionality and sensing to allow physicians to deliver precise, patient-specific DBS therapy to treat symptoms associated with movement disorders.
  • The company touts SenSight as the first directional, sensing-enabled lead designed to improve the detection of local field potentials.
  • Price Action: MDT shares are up 0.21% at $124.11 during the market session on the last check Monday.
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Posted In: NewsHealth CareFDAGeneralAtrial FibrillationBriefs
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