Medtronic, Inc. (NYSE: MDT) today announced the global launch of the Defeat-HF (Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure) clinical trial. It is the industry's first prospective, randomized study evaluating the clinical feasibility of spinal cord stimulation (SCS), or neurostimulation, to improve clinical signs and symptoms of heart failure.
“This clinical trial will explore the potential for neurostimulation to help physicians provide additional device therapy options for the growing population of heart failure patients”
More than 5 million Americans and 22 million people worldwide have heart failure and it is a leading cause of hospitalization. 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 unique collaboration of cardiologists and neurosurgeons on this novel feasibility trial has the potential to identify new technologies to treat more heart failure patients and specifically slow the deterioration of patients with advanced heart failure," said Cecilia Linde, M.D., Ph.D., Defeat-HF investigator and cardiologist at the Karolinska University Hospital in Stockholm, Sweden, who enrolled the first patient. The implantation was performed by neurosurgeons Prof. Bengt Linderoth, M.D., and Dr. Goran Lind, M.D.
Neurostimulation uses an implantable pulse generator (IPG), or neurostimulator, similar to a cardiac pacemaker, with a lead, or thin wire, connecting the device to the spinal cord to deliver low-intensity electrical pulses. The procedure includes percutaneous placement of the leads in the spinal column and the stop-watch-sized neurostimulator is typically implanted in the abdomen.
"This clinical trial will explore the potential for neurostimulation to help physicians provide additional device therapy options for the growing population of heart failure patients," said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "Medtronic is proud to continue our leadership in the heart failure therapy and diagnostic market and is uniquely positioned to evaluate this disruptive technology."
As the pioneer in neuromodulation, Medtronic technologies already have gained significant medical acceptance, including SCS for chronic back and leg pain, deep brain stimulation for movement disorders and sacral nerve stimulation for the debilitating symptoms of overactive bladder. There are also neurostimulation therapies approved under Humanitarian Device Exemptions (HDEs) for severe obsessive-compulsive disorder and the nausea and vomiting associated with severe gastroparesis. There are more than 20 years of literature supporting SCS for cardiovascular applications.
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