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Medtronic heart failure trial

This article was originally published in The Gray Sheet

Executive Summary

Medtronic-supported investigators are enrolling up to 70 patients in what the firm says will be the first prospective, randomized study to evaluate the clinical feasibility of spinal cord stimulation to treat heart failure. The Defeat-HF feasibility trial will follow patients at up to 15 centers in Europe and the U.S. for one year. Patients will be implanted with Medtronic's PrimeADVANCED neurostimulator, and researchers will measure improvement in metrics including heart size, muscle wall thickness and the heart's efficiency in carrying oxygen. The device is currently approved to treat chronic pain. Medtronic launched Defeat-HF July 29, though plans for the trial were first announced in May at the Heart Rhythm Society meeting ("1The Gray Sheet" May 17, 2010)

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Neurostimulation for heart failure: Medtronic will launch a study to evaluate spinal cord stimulation for the treatment of heart failure in the next few weeks, cardiologist Douglas Zipes announced at HRS. Zipes and other speakers discussed the emerging role of neurostimulation devices, such as Medtronic's PrimeADVANCED neurostimulator and BioControl Medica's CardioFit vagus nerve stimulation device, to treat heart failure and cardiac arrhythmias. Neither devices are approved in the U.S. "There is a huge market for improving ventricular function over the present therapies," such as defibrillation, Zipes, of Krannert Institute of Cardiology in Indianapolis, said. "This is a major advance." Zipes will be lead investigator of Medtronic's DEFEAT-HF study

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