Company Plans Clinical Trial of Autonomic Regulation Therapy to Treat Heart Failure

According to a story from Compelo, the medical technology company LivaNova is kicking off an international trial that will assess the use of autonomic regulation therapy as a treatment for heart failure. Specifically, the company expects to use the therapy in order to halt the progression of heart failure that presents with preserved ejection fraction, which occurs in about half of people who experience heart failure. 

About Heart Failure

Heart failure itself is not a rare complication as it impacts roughly 20 million people worldwide and it can appear with a variety of diseases and conditions, both rare and common. Some rare conditions that are associated with and can cause heart failure include pulmonary arterial hypertension, sarcoidosis, and amyloidosis. Symptoms of heart failure with preserved injection fraction include edema, elevated pressure of the jugular vein, shortness of breath, fatigue, and exercise intolerance. 

The Autonomic Regulation Therapy System

The autonomic regulation therapy system is known as Vitaria. The system is designed to supplement the therapy system with vagus nerve stimulation for those patients that continue to experience symptoms even after receiving other medical therapy. Last year Vitaria earned expedited pathway designation as a breakthrough technology from the US Food and Drug Administration.

If the trial results are favorable, the Vitaria system would be the first active neurostimulation system that can be implanted. The autonomic regulation therapy system is derived from LivaNova’s prior experience developing the vague nerve stimulation system, which has been used to treat a number of other disorders. The company is specifically focused on developing new technology and medical devices designed to maintain and supplement healthy heart function.

Other recent activity of the LivaNova company includes another international trial which will compare the effectiveness of a sutureless aortic valve replacement operation alongside the current aortic valve replacement standard. This trial will include a total of 900 different patients from 12 countries.


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