By Ben Hirschler
BARCELONA (Reuters) - A Boston Scientific device that stimulates the vagus nerve – a superhighway connecting the brain to the rest of the body - failed to help patients with heart failure in a mid-stage clinical trial.
Vagus nerve stimulation (VNS), which involves delivering mild electrical pulses to the nerve in the neck, is already used to treat epilepsy and depression - and researchers have been looking to expand its use to other conditions.
Faiez Zannad from the University of Lorraine in France, who led the study, said the failure of the device to improve cardiac function was surprising as pre-clinical research findings had been promising.
Heart failure is a serious, progressive disease in which the heart fails to pump blood properly. It causes shortness of breath, fatigue and fluid retention, and is often fatal.
Results from the U.S. medical technology company's NECTAR-HF trial, involving 95 heart failure patients in Europe, were unveiled on Saturday at the annual meeting of the European Society of Cardiology (ESC).
Patients enrolled in the study had a VNS device implanted in their neck, near the right vagus nerve. Some of the patients had the devices switched off, while the others received regular stimulation. After six months, the study found no difference between the two groups.
The result is a disappointment for Boston Scientific and Zannad said there were several possible explanations, including the fact that a stronger electrical pulse may have been needed and it might take longer than six months to show a benefit.
Boston Scientific officials were not immediately available to comment.
Cyberonics, the leading proponent of VNS in difficult-to-treat epilepsy and treatment-resistant depression, is also to present results from a clinical study in heart failure to the ESC meeting on Monday.
VNS involves a pacemaker-like device the size of a small watch being surgically implanted under the skin on the patient's chest. A wire is then threaded under the skin connecting it to the vagus nerve and, when activated, the device sends electrical signals to various areas of the brain.
(Reporting by Ben Hirschler. Editing by Jane Merriman)