Europe and Australia have already approved the system — the first to target specific nerve cells in the brain. It does this by stimulating electrodes that surgeons implant there.
“This [U.S.] 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,”Maulik Nanavaty, the president of Boston Scientific, said in a news release. “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 implants are an “effective surgery that can be applied to treat some of Parkinson’s debilitating motor symptoms caused by abnormal brain activity,” Nanavaty added.
After implanting the electrodes deep in the brain, surgeons connect them to a pacemaker-like stimulating device. Its electric pulses block faulty nerve signals that lead to erratic movement.
Several deep brain stimulation systems are on the market. Vercise is the smallest and the only one with fine control of stimulation position and shape. This allows patients to focus on the right brain areas with minimal side effects. Vercise’s wifi-rechargeable battery lasts about 15 years.
Boston Scientific conducted two clinical trials to evaluate Vercise’s safety and ability to improve the movement of people in advanced stages of Parkinson’s.
The INTREPID study (NCT01839396) covered 292 patients at 23 U.S. medical centers. All used a Vercise for 12 weeks. Researchers varied the settings so that some patients received more stimulation than others.
Preliminary results showed that 160 patients had better movement control. Boston Scientific plans to release a detailed report on the results in 2018.
The company conducted the VANTAGE trial (NCT01221948) in Europe. Surgeons implanted electrodes in 40 of the 53 patients in the study.
Vercise improved patients’ movement control by 62 percent over six months. This led to them reporting better quality of life scores as well. Three adverse effects occurred, but all were resolved.
Meanwhile, the University of Minnesota Medical School in Minneapolis has agreed to do the first surgical implant of the Vercise system in the United States. The surgery team will be headed by Drs. Jerry Vitek, Michael C. Park and Lauren E. Schrock.
Boston Scientific is also working on deep brain stimulation as a way to treat Alzheimer’s disease and to help stroke victims recover.