AIGISRx N Antibacterial Envelope Receives FDA Clearance

TYRX Inc's AIGISRx N Antibacterial Envelope has been given marketing clearance by FDA.

The device is used in conjunction with vagus nerve stimulation (VNS) therapy, which helps to improve symptoms in patients with depression or seizure disorders such as epilepsy.

Helping to hold the implanted pulse generator in place, the envelope ensures a stable environment which results in superior clinical outcomes.

It works similarly to a pacemaker, delivering an electrical current at regular intervals — according to the Epilepsy Society, 30 seconds every 5 minutes is typical.

Electricity is delivered to the vagus nerve, in the left side of the neck, in order to stimulate the nucleus of the tractus solitarius (NTS) — a part of the brain involved in seizures.

Antimicrobial agents rifampin and minocycline are incorporated into the mesh of the product to help reduce the risk of surgical site infections (SSIs).

"Securing the FDA clearance to offer our AIGISRx technology to patients and physicians in the neurosurgery arena is an important milestone," said TYRX president and chief executive Robert White.