A study of the PrimeADVANCED neurostimulator will determine whether spinal cord stimulation can play a key role in the treatment of heart failure.
This article originally appeared at Medgadget.com, part of the HCPLive network.
Medtronic announced the start of its Defeat-HF study, in which the company will attempt to treat heart failure through the use of spinal cord stimulation (SCS). Trial subjects will be implanted with Medtronic's PrimeADVANCED neurostimulation device, which is currently being used for pain management. The treatment's efficacy will be evaluated based on heart size, muscle wall thickness, fatigue, shortness of breath, and quality of life improvements.
An explanation from Medtronic's press release:
Heart failure stimulates the sympathetic nervous system further progressing the disease. The Defeat-HF study will evaluate whether SCS can restore the natural balance between the sympathetic and parasympathetic nervous systems to improve blood flow, reduce inflammation and restore the heart’s dimensions and function. The study will be conducted under an Investigational Device Exemption (IDE) in the United States.
The prospective, randomized, feasibility trial is expected to enroll NYHA Class III systolic heart failure patients at up to 15 centers worldwide. All patients are implanted with a Medtronic PrimeADVANCED™ neurostimulator and followed for 12 months. In this trial, the device delivers stimulation for 12 hours a day.
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