Cyberonics’ AspireSR Generator Snags FDA Approval

Cyberonics’ AspireSR generator for VNS therapy has won FDA approval, the Houston, Texas, devicemaker announced Tuesday.

The company says the device is the first of its kind, capable of administering responsive stimulation to heart rate increases that are associated with seizures in epileptic patients. Seizures are often unpredictable and can be life-threatening.

The system works through implantation under the skin of the chest, delivering pulsed electrical signals to the vagus nerve, which is implicated in brain seizure activity. Clinical trials demonstrated that drug-resistant epileptic patients implanted with the device saw a 50 percent to 90 percent decrease in seizures and reported a higher quality of life, the company claims.

The AspireSR generator won CE Mark approval in 2014.

Epilepsy is the fourth most common neurological disorder; one in 26 people will develop the disease during their life. — Jason Scott