Boston Scientific wins CE mark for deep-brain visualizer

Boston Scientific won CE mark approval for the Guide DBS system, used with the Vercise implant.--Courtesy of Boston Scientific

Boston Scientific ($BSX) notched European approval for its Guide DBS system, a first-of-its-kind platform designed to help physicians target neuromodulation therapy.

The system works with Boston Scientific's Vercise deep-brain stimulation implant, providing 3-D images of the brain and simulations of treatments, which the company said could reduce programming time and enable more precise targeting. Vercise competes with similar devices from St. Jude Medical ($STJ) and Medtronic ($MDT), but Guide DBS' precision and modeling capabilities make the whole system a unique offering, Neuromodulation President Maulik Nanavaty said.

"Guide DBS is a groundbreaking technology," Nanavaty said in a statement. "This innovative system is the first of its kind and designed to help physicians provide better therapy for their patients and improve programming time."

Vercise is already CE marked to treat Parkinson's disease, and neither it nor Guide DBS has received FDA approval.

Boston Scientific is well entrenched in CEO Mike Mahoney's plan to return the company to growth through new device launches and budget cuts, plotting to shed another 1,000 jobs and direct R&D funds toward in-demand technologies. In part, that means focusing on neuromodulation. 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.

Meanwhile, the company took a $354 million loss in the first quarter, as the flagging market for implanted cardiac device joined a spike in charges to slash the company's profitability. Still, Mahoney maintains that Boston Scientific is on the path to a strong 2013, pointing to the company's promising heart valve, resorbable stent and renal denervation system.

- read the announcement