New Research Supports the Effectiveness of Parasym’s Neuromodulation Treatment for Heart Failure

Parasym, in partnership with the University of Oklahoma, has shared research into neuromodulation treatment for heart failure. 
 
The randomized-controlled trial, led by principal investigator Dr. Stavros Stavrakis at the University of Oklahoma’s Health Sciences Center used the Parasym neuromodulation device to significantly improve cardiac mechanics and quality of life and reductions in inflammatory markers in a patient population that historically has very few treatment options available. The positive results could pave the way for a new era of heart failure treatment.
 
Currently, heart disease is the leading cause of death globally, taking an estimated 17.9 million lives each year. As the fastest growing form of heart disease, heart failure is accounting for a significant proportion of all cases.
 
Today’s landscape for heart failure is complex as there is no cure for the debilitating condition. Until Parasym launched its neuromodulation device, there was no clinically validated, non-invasive, non-pharmacological options for people who suffer from heart failure and its plethora of life-altering symptoms.
 
As many as one-quarter of patients report intermediate to severe depression in association with heart disease because it drastically impacts their quality of life. Additionally, there are many risks and possible side effects of taking medication to treat the disease, which is mostly triggered by the right medicine ending up in the wrong places. Whereas, neuromodulation and electroceuticals have the capacity to provide a highly targeted treatment.
 
Current treatment advises lifestyle changes and medication, which is not without side effects. Electroceuticals are set to revolutionize the treatment paradigm in heart failure, especially neuromodulation with its capacity to provide highly targeted treatment without drug interaction or side effects.
 
The results from the clinical trial using Parasym’s neuromodulation device demonstrate that Parasym—the only non-invasive, low risk and minimal side effect option—has significantly improved the quality of life for patients suffering from heart failure.
 
The device works by stimulating the vagus nerve and sending signals to the brain, which favorably alter the nervous system and reduce inflammation of the heart.

Clinical Results

The clinical results of using neuromodulation to help significantly ease the symptoms of heart failure showed that the patients who took part in the placebo-controlled study experienced measurable improvements from as little as three months of using the device for less than an hour per day. The study revealed significant improvements in levels of proinflammatory cytokines Interleukin-8 and Tumor Necrosis Factor alpha, indicating that the treatment had a significant anti-inflammatory effect, as well as in global longitudinal strain, a core indicator of cardiac mechanics. 
 
Importantly, patients also reported improved quality of life and in their day-to-day activities, which is something that surgery and medication struggle to deliver. Furthermore, as the neuromodulation device is non-invasive, patients are able to use it in addition to medication should they want to. This approach fills a gap by addressing the patient’s overall quality of life, as well as improving their mental health which is impacted by living with the condition. 
 
Dr. Stavros Stavrakis said, “Our results support the emerging paradigm of noninvasive neuromodulation to treat selected patients with heart failure with preserved ejection fraction and provide the basis for further randomized trials.”
 
Sophie Dundovic, co-founder at Parasym added, “The results published in the Journal of the American Heart Association highlight the brilliant work done by researchers at the University of Oklahoma and show the incredible potential that Parasym’s neuromodulatory technology can have in a condition where there is an urgent unmet clinical need for new treatment options. We are incredibly proud of the trial results and hope to continue to demonstrate the positive impact of neuromodulation in healthcare.”