Medtronic 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, randomised study evaluating the clinical feasibility of spinal cord stimulation (SCS), or neurostimulation, to improve clinical signs and symptoms of heart failure.
The condition, which affects more than 5 million Americans and 22 million people worldwide, 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, improving blood flow, reducing inflammation and restoring the heart’s dimensions and function.
“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 Dr Cecilia Linde, Defeat-HF investigator and cardiologist at the Karolinska University Hospital in Stockholm, Sweden, who enrolled the first patient. The implantation was performed by neurosurgeons Bengt Linderoth and Goran Lind.
Neurostimulation uses an implantable pulse generator (IPG), or neurostimulator – similar to a cardiac pacemaker – with a lead, connecting the device to the spinal cord to deliver low-intensity electrical pulses. The procedure also involves 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, Medtronic senior vice president. “Medtronic is proud to continue our leadership in the heart failure therapy and diagnostic market and is uniquely positioned to evaluate this disruptive technology.”