Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its Vercise deep brain stimulation (DBS) system.
DBS will be used for the treatment of Parkinson's disease (PD) symptoms. The disease is a degenerative condition that affects over one million people in the US and 10 million across the globe.
The FDA approved the system based on the Intrepid study, which is claimed to be the first first multi-center, prospective, double-blind and randomized sham-controlled trial of DBS for PD in the US.
The trial assessed the safety and effectiveness of the system in 292 patients at 23 sites.
According to the company, the study achieved its primary endpoint of mean change in waking hours with good symptom control.
The approval was also supported by safety data from the European multi-center, prospective and single-arm Vantage study.
In 2012, the company first introduced the Vercise system, which was developed based on cochlear implant technology.
Recently, the company launched new programming software called Neural Navigator 2 to help physicians visualizing the stimulation field while configuring DBS programs for patients.
Boston Scientific neuromodulation senior vice president and 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."
Image: Boston Scientific's corporate headquarters in Marlborough, Massachusetts. Photo: courtesy of Boston Scientific Corporation.