Medtronic Inc. (NYSE:MDT) launched a global, randomized clinical trial to see if spinal cord stimulation can slow the progression of heart failure.
It’s an intriguing collaboration between two of the Fridley, Minn.-based company’s major markets—cardiac rhythm management and neuromodulation. Under CEO Bill Hawkins’ "One Medtronic" strategy, the company is seeking to drive greater collaboration and synergies from the company’s once disparate business units.
"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," Pat Mackin, president of Medtronic’s Cardiac Rhythm Disease Management business, said in a prepared statement.
Until now, spinal cord stimulation has been primarily used to treat back and leg pain. Now Medtronic thinks SCS can help heart failure patients. Here’s how the theory works: heart failure kick starts the sympathetic nerve system, which controls the body’s fight-or-flight response, into overdrive and releases energy and adrenaline throughout the body. The heart beats faster as a result, which only furthers the cardiac damage.
Medtronic proposes to shoot low levels of electricity into the spinal cord to activate the parasympathetic nerve system, the natural check to sympathetic nerves. In other words, parasympathetic nerves act as the brake to the sympathetic nerves’ gas pedal.
By restoring balance between the two nerve systems, Medtronic believes it can improve blood and oxygen flow to the heart, strengthen cardiac walls, reduce inflammation and restore the heart to its natural size.
"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," Dr. Cecilia Linde, the study’s lead investigator and cardiologist at the Karolinska University Hospital in Stockholm, Sweden, said in a prepared statement.
The Food & Drug Administration granted Medtronic an Investigational Device Exemption to conduct the trial in the United States. The 12 month study includes patients receiving 12 hours of stimulation per day at 15 centers throughout the world.