The US Food and Drug Administration (FDA) has approved Boston Scientific’s Vercise Deep Brain Stimulation (DBS) System for the treatment of Parkinson’s disease symptoms.
A DBS system is designed to trigger a targeted region of the brain through implanted leads powered by a device called implantable pulse generator (IPG).
The small, rechargeable Vercise system features a capability to independently regulate the amount of current to be delivered by each electrode on the implanted leads.
This adaptable stimulation delivery is intended to address symptom fluctuations of the disease and its progressive nature.
The Vercise system leads come with eight contacts having a total span of 15.5mm and tight spacing between contacts of 0.5mm with multi-lumen construction.
Boston Scientific Neuromodulation president and senior vice-president Maulik Nanavaty said: “This approval marks an important step for patients who will now have the choice to be treated with one of the most innovative neuromodulation technologies available today.
“Our system stands apart from the field in its approach and is changing the traditional definition on how we can leverage technology to treat patients with Parkinson’s disease.”
The FDA approval is based on the positive findings from the multi-centre, prospective, double-blind, randomised sham-controlled INTREPID study conducted in 292 subjects at 23 centres in the country.
These results were supported by safety data obtained during the multi-centre, prospective, single-arm VANTAGE trial in 40 European patients.
Boston Scientific intends to carry out the first commercial implant using the Vercise System at the University of Minnesota Medical Centre in Minneapolis, US.