Medtronic has launched the Defeat-HF (Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure) clinical trial. It is the prospective, randomised study designed to evaluate the clinical feasibility of spinal cord stimulation (SCS), or neurostimulation, to improve clinical signs and symptoms of heart failure.
According to Medtronic, the Defeat-HF study is expected to 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 is expected to be conducted under an Investigational Device Exemption (IDE) in the US.
Medtronic said that the 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.
Pat Mackin, president of the cardiac rhythm disease management business and senior vice president at Medtronic, said: “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.
“Medtronic is proud to continue our leadership in the heart failure therapy and diagnostic market and is uniquely positioned to evaluate this disruptive technology.”
Cecilia Linde, investigator of Defeat-HF trial and cardiologist at the Karolinska University Hospital in Stockholm, Sweden, said: “The collaboration of cardiologists and neurosurgeons on this 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.”