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Boston Scientific expanding Parkinson’s studies

Posted: May 1, 2014 1:58 p.m.
Updated: May 1, 2014 1:58 p.m.

A dummy demonstrates Boston Scientific's deep brain stimulation system to treat Parkinson's disease.

 

Boston Scientific is enrolling patients in two studies for its Vercise Deep Brain Stimulation System in patients with Parkinson's disease.

The first study is a global one in countries where the biomedical device is already approved and in commercial use. The company has begun enrolling what it calls “real world” patients for a broader study.

Boston Scientific expects the global study to look at some 300 people, collecting a larger body of data, so it can build sufficient data to help physicians plan for the best outcomes.

In the U.S. study, clinical trials for the FDA will be conducted at some 15 sites around the country – like hospitals and teaching institutions – where they have deep expertise and treatment experience with Parkinson’s, said Dr. Maulik Nanavaty, president of the Neuromodulation business unit at Santa Clarita’s Boston Scientific.

Boston Scientific expects to enroll anywhere from 150 to 300 patients and expects the U.S.-based Intrepid clinical trial to span a one- to three-year timeframe, Nanavaty said.

Parkinson’s is a chronic and progressive neurological disorder that affects 6.3 million people worldwide, according to the European Brain Council. Currently, there is known no cure.

Boston Scientific’s deep brain stimulation device and system, Vercise DBS, provides an alternative to treatment through medication.

An implantable device, Boston Scientific’s system delivers targeted electrical signals to specific areas in the brain through individual lead contacts that are implanted.

Use of the electrical stimulation device also greatly reduces the need for medication, which also causes side effects in many patients.

The electrical stimulation device helps to control the symptoms, said Deanna Harshbarger, global director of DBS for Boston Scientific. Symptoms of the disease include tremors, difficulty moving or slowness of moving, she said.

Treating the disease with the Vercise DBS system may be groundbreaking.

Trials overseas, where the device was approved, demonstrated a 62 percent improvement in motor function, daily living activities and overall quality of life.

And the medical technology may have future applications. In an earlier interview with the SCVBJ, Nanavaty said researchers are on the future frontier of brain research. And they are looking at how to stimulate other areas of the brain.

“We believe that this is just the beginning. We are looking at all the different areas and doing some early work,” he said at the time. “It’s exciting for us. We’re making a difference in peoples’ lives.”

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