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Medtronic tests spinal cord stimulation in heart failure

This article was originally published in Clinica

Executive Summary

Medtronic has started a randomised study evaluating the clinical feasibility of using spinal cord stimulation (SCS), a form of neurostimulation, to improve heart failure. The Defeat-HF trial will be conducted under an investigational device exemption (IDE) in the US and will enrol patients with NYHA Class III systolic heart failure. All patients will be implanted with Medtronic's PrimeADVANCED neurostimulator, which will deliver stimulation for 12 hours per day, and followed for 12 months. The trial will assess patients' heart size and muscle wall thickness, their hearts' efficiency in carrying oxygen, and heart failure symptoms like fatigue, shortness of breath, and quality of life. Metrics will be measured throughout the trial. The PrimeADVANCED device is already approved as a therapy for severe chronic pain, including back and leg pain, complex regional pain syndrome and painful neuropathy. It is not yet approved to treat heart failure.

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