The device, initially launched in Europe in 2012, was developed based on cochlear implant technology and is designed to stimulate a targeted region of the brain through implanted leads powered by an implantable pulse generator. The device also has the ability to independently control the amount of current delivered on each lead, the company 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,” neuromod prez Maulik Nanavaty said in a press release.
Approval of the device came based on data from the Intrepid study of the device which evaluated the use of the system in 292 patients across 23 sites. The trial met its primary endpoint of mean change in waking hours with good symptom control, and full data from the trial is expected to be released next year.
FDA approval was also supported by safety data from the Vantage study of the device, in which 40 patients treated with the Vercise DBS were shown to have a 63% improvement in motor function at 1 year from baseline as measured by the United Parkinson’s Disease Rating Scale III. Patients also showed improvements in quality of life and medication usage the company said.
“The Vercise DBS System changes the landscape of what physicians can do to help improve the quality of life for people living with Parkinson’s disease. This system provides an ability to sculpt the current field in the DBS target using novel technology that offers flexibility in programming. This flexibility allows us to target different regions of the subthalamic nucleus, which we believe will improve outcomes while reducing side effects,” Intrepid coordinating principal investigator Dr. Jerry Vitek of the Univeristy of Minnesota Medical Center said in a prepared statement.
The 1st commercial implantation of the device is slated to take place at the Univeristy of Minnesota Medical Center, the Marlborough, Mass.-based company said.
In late November, Boston Scientific saw its market capitalization lose $3 billion after revealing another delay for its Lotus replacement heart valve.
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