Boston Scientific Receives CE Mark for Vercise™ Gevia™ Deep Brain Stimulation System

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Industry’s First MR-Conditional Directional DBS System with Stimulation Visualization

Boston Scientific (NYSE: BSX) has received CE mark for the Vercise™ Gevia™ Deep Brain Stimulation (DBS) System*, a rechargeable, magnetic resonance (MR) conditional device indicated for the treatment of movement disorder symptoms in patients with Parkinson’s disease, dystonia and essential tremor. The system features the Vercise Neural Navigator 2 with STIMVIEW Technology, programming software which, for the first time, allows clinicians to visualize the stimulation field while configuring DBS stimulation programs for patients.

DBS therapy involves the placement of a device that stimulates specific areas in the brain using electrical signals. The Vercise Gevia System is a next generation rechargeable platform with an unparalleled 25-year battery life.

The approval expands the Vercise Directional portfolio which is composed of the Vercise Primary Cell (PC) and Vercise Gevia platforms with Vercise Cartesia™ Directional Lead*. The Vercise Directional offerings are the only DBS solutions that finely control the size, shape and direction of stimulation with multiple independent current control technology (MICC). This level of precision in delivering accurate stimulation therapy to the neural target is critical for avoiding unwanted side effects and obtaining optimal DBS outcomes.

“The Gevia System addresses the needs of both patients and physicians with the latest advances in DBS therapy,” said Ludvic Zrinzo, M.D., Ph.D., FRCSEd, consultant neurosurgeon, National Hospital for Neurology and Neurosurgery, Queen Square, London. “With the Gevia System, patients benefit from directional stimulation within a rechargeable system while maintaining the ability to have an MRI. This flexibility in DBS therapy is a clear step forward for patients.”

The Neural Navigator 2 software enables a physician to visualize how stimulation will be distributed in the brain while programming therapy for a patient. Typically, physicians rely primarily on patient feedback to complete programming. This software provides an additional source of information which is designed to provide optimal therapeutic results.

“I now have the potential to better define the settings that can help patients because I have the ability to visualize their stimulation field while I am programming,” said Professor Patricia Limousin, M.D., Ph.D., neurologist, National Hospital for Neurology and Neurosurgery, Queens Square, London. “The Neural Navigator software brings together some of the most critical information I need to customize therapy for patients.”

“Five years ago, Boston Scientific was the first to bring an eight contact rechargeable platform offering 25 years of longevity, quickly followed by the introduction of the first directional lead powered by a small primary cell device,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “Today, we are thrilled to provide the first rechargeable, directional DBS system that is also Full Body MRI Conditional1 and the first programming software with STIMVIEW Technology. Boston Scientific is dedicated to providing transformative technology to equip clinicians and improve the lives of patients.”

Parkinson’s disease is a progressive neurodegenerative disorder that impacts one’s ability to move and causes changes in mood, sleep patterns and cognition. It affects nearly 10 million people worldwide.2 Dystonia causes muscles to involuntarily contract and affects nearly 72 million people globally and is diagnosed more often in women.3 Essential tremor is the most common movement disorder and is characterized by tremors in different parts of the body. The incidence of essential tremor increase with age with approximately 4 percent of the global population and up to 14 percent of the elderly being diagnosed.4

References

*The Gevia DBS System,Vercise Primary Cell and Vercise Gevia platforms with Vercise Cartesia Directional Lead are not available for use or sale in the U.S.
1.1.5 Tesla MR conditional when all conditions of use are met
2. http://www.pdf.org/parkinson_statistics
3. http://www.webmd.com/brain/dystonia-causes-types-symptoms-and-treatments#1
4. http://www.medscape.org/viewarticle/740330_3
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