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Medical equipment industry

Medtronic Receives FDA Approval for V-V Timing on CRT-Ds

Strategic Insights

— 2 min read

Medtronic, Inc. has received approval from the U.S. Food and Drug Administration (FDA) to add sequential biventricular pacing or "V-V (ventricle to ventricle) timing" to its InSync Sentry and InSync Maximo cardiac resynchronization therapy defibrillators (CRT-Ds). This advancement allows physicians to separately adjust the timing of electrical therapy delivered to the heart failure patient's two ventricles, enhancing the flow of blood throughout the body. The FDA approved a labeling modification for InSync Sentry and InSync Maximo systems to include use for heart failure patients who have prolonged QRS duration.

Key Takeaways:

  • The FDA approval of V-V timing will allow physicians to optimize the beating of the heart and enhance blood flow in heart failure patients with prolonged QRS duration.
  • The feature will be available on new shipments of InSync Sentry and InSync Maximo devices, starting in the next two weeks.
  • Special software will be released to enable patients with previous models of these devices to benefit from the feature through a simple, in-clinic software programming change.
  • Medtronic's InSync Sentry system is the world's first implantable medical therapy offering automatic fluid status monitoring in the thoracic cavity, providing a critical advantage in managing heart failure.
  • The company's CRT-D systems are the most widely implanted CRT-D systems in the world, and their CRT-D product portfolio includes devices with the longest battery life available.
  • Patients with heart failure are six to nine times more likely to suffer an episode of sudden cardiac arrest than the general population, according to the American Heart Association.
  • Dr. William Abraham, chief of cardiology at The Ohio State University, presented clinical data about patient response to V-V timing in the InSync III Marquis clinical trial, a Medtronic-sponsored study.
  • Medtronic's president of Cardiac Rhythm Management, Steve Mahle, stated that the company's aim is to help patients experience a better quality of life while also helping physicians and hospitals contain healthcare costs.

Statistics:

  • Patients with heart failure are six to nine times more likely to suffer an episode of sudden cardiac arrest than the general population (American Heart Association).
  • Medtronic's CRT-D systems are the most widely implanted CRT-D systems in the world.
  • Medtronic's CRT-D product portfolio includes devices with the longest battery life available.
  • The InSync Sentry system offers automatic fluid status monitoring in the thoracic cavity.

Sources:

  • NewsRx.com, Health & Medicine Week
  • William Abraham, chief of cardiology at The Ohio State University
  • Steve Mahle, president of Cardiac Rhythm Management at Medtronic
  • American Heart Association
  • Medtronic, Inc.

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