Boston Scientific targets FDA with brain-stim trial

Boston Scientific is studying the Vercise stimulator with an eye on FDA approval.--Courtesy of Boston Scientific

Boston Scientific ($BSX) has its eye on FDA approval for a deep-brain stimulator designed to treat Parkinson's disease, launching a large-scale trial of the Vercise DBS System.

The device, which won a CE mark back in September, runs leads into the brain, delivering electrical stimulation to improve motor function and quality of life in Parkinson's patients. Unlike other DBS devices, Vercise is paired with 3-D imaging technology that allows physicians to target stimulation for each patient, allowing for a first-of-its-kind customized treatment, co-principal investigator Philip Starr said.

"The indications for deep brain stimulation are rapidly expanding, while innovations in the devices used for this therapy have been slower," Starr said in a statement. "The launch of this trial heralds advanced innovation in device development which is greatly needed."

In 6-month data from a previous trial, Vercise delivered a 60% average improvement in motor function in 40 patients with 100% implant success. Those results set the table for further demonstrations of Vercise's safety and effectiveness, Neuromodulation President Maulik Nanavaty said, and Boston Scientific plans to build on the device's success on the way to FDA approval.

Boston Scientific is slogging through a long-term effort to slash costs and grow revenues, planning to hack off another 1,000 jobs this year and direct R&D funds toward in-demand technologies. That's where neuromodulation comes in: The company's fastest-growing unit posted a 9% revenue jump in 2012 and a 14% leap in the fourth quarter alone thanks to strong sales for DBS devices like Vercise and neurostimulators like the FDA-approved Precision Spectra.

Last quarter, Boston Scientific took a $354 million loss, but CEO Mike Mahoney maintains that the company is on the path to post revenue growth for the whole year.

- read the study announcement
- check out the previous results

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