FDA approves Cyberonics' new VNS generator
This article was originally published in Clinica
Executive Summary
The US FDA has approved AspireHC, a generator for vagus nerve stimulation (VNS) therapy developed by Cyberonics, via a premarket approval (PMA) supplement. The firm's VNS device is approved to treat drug-resistant epilepsy and depression by using electrodes to stimulate the vagus nerve in the neck. The fifth-generation AspireHC generator is implanted in the chest and sends impulses via leads to these electrodes. The device's main advantage over previous-generation products is a longer battery life, which could range from three to 11 years depending on how aggressively the patient is managed, Cyberonics told Clinica. "Aspire will probably be ideal for patients who need aggressive treatment," a spokesperson said.