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Deep-brain stimulation

Boston Scientific wins CE Mark for Vercise Gevia DBS

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Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for its Vercise Gevia deep-brain stimulation device for treating movement disorder symptoms. Marlborough, Mass.-based Boston Scientific said the new system features programming software called the Vercise Neural Navigator 2 with Stimview, designed to allow physicians to see images of the stimulation field while the […]

FDA clears Medtronic’s StealthStation DBS lead placement software

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Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for its StealthStation software, which is designed to help plan the placement of the leads used for deep-brain stimulation therapy. Fridley, Minn.-based Medtronic said StealthStation is designed to work with its O-arm imaging system to integrate pre-operative planning and intraoperative imaging during DBS device implantations. “The […]

Medtronic wins CE Mark for SureTune2 DBS software

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Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for the SureTune2 software used with its deep-brain stimulation devices. The software is designed to allow physicians to fine-tune patients’ therapy “by visualizing patient-specific information in one comprehensive view including anatomy, physiology, and calculated stimulation field,” the Fridley, Minn.-based company said. “Medtronic […]

Medtronic warns on wire fracture risk with Activa DBS devices

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Medtronic (NYSE:MDT) last month cautioned surgeons to be careful not to implant its Activa deep-brain stimulation devices with sharply bent or kinked wires, after receiving reports of wire fracture. In a June letter to physicians, Fridley, Minn.-based Medtronic said it learned of 16 instances of high impedance measurements that were later found to be caused […]

FDA expands approval for Medtronic’s deep-brain stimulation for Parkinson’s

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Medtronic (NYSE:MDT) said today that it won expanded approval for its deep-brain stimulation therapy for patients with Parkinson’s disease, which 1st won approval from the safety watchdog in 2002. The expanded approval covers patients who have had a Parkinson’s diagnosis for 4 years and recently developed motor complications, or have long-standing motor complications that can’t be […]

St. Jude Medical wins CE Mark for Infinity DBS device

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St. Jude Medical (NYSE:STJ) said today that it won CE Mark approval in the European Union for its Infinity deep-brain stimulation device and directional lead for treating movement disorders. Little Canada, Minn.-based St. Jude said the Infinity system is designed so that Apple (NSDQ:AAPL) mobile devices can be used as wireless controllers, via a Bluetooth connection. It’s […]