Medtronic has launched the Defeat-HF (Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure), a prospective, randomized trial evaluating the clinical feasibility of spinal cord stimulation (SCS), or neurostimulation, to improve clinical signs and symptoms of heart failure.
The Defeat-HF study will evaluate whether SCS can restore the 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 U.S.
Neurostimulation uses an implantable pulse generator, or neurostimulator, similar to a cardiac pacemaker, with a lead connecting the device to the spinal cord to deliver low-intensity electrical pulses, said the Minneapolis-based Medtronic. The procedure includes percutaneous placement of the leads in the spinal column and the stopwatch-sized neurostimulator is typically implanted in the abdomen.
The collaboration of cardiologists and neurosurgeons on this feasibility trial has the potential to identify new technologies to treat more heart failure patients and slow the deterioration of patients with advanced heart failure, according to Cecilia Linde, MD, PhD, 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, MD, and Goran Lind, MD.