CE Mark for Boston Scientific’s VERCISE™ Neural Navigator 3 Programming Software

Boston Scientific Corporation has announced the CE Mark approval of its Vercise™ Neural Navigator 3 directional Deep Brain Stimulation (DBS) programming software.

Background

An estimated ten million people worldwide are affected by Parkinson’s disease, causing symptoms such as shaking or tremors, muscle stiffness, and slowness of movement. Dystonia is a neurological movement disorder that affects more than half a million men, women, and children across Europe. The Vercise Directional System, with the Vercise Cartesia Directional Lead, is designed to treat the symptoms of Parkinson’s Disease (PD), Essential Tremor, and Primary and Secondary Dystonia by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.

Boston Scientific says Vercise™ Neural Navigator 3 is the first system to integrate patient-specific 3D brain anatomy and stimulation field modeling into the clinician’s programming interface. When used in conjunction with the Vercise Directional DBS System, this innovation is intended to empower physicians to accurately and efficiently optimize personalized DBS therapies for their patients.

The Vercise Neural Navigator 3 programming software features STIMVIEW XT, which is the most advanced, visualization capability built for DBS programming. A study found that overall programming time with the first-generation GUIDE System was significantly shorter than traditional programming time (n=10, p<0.0001).  Shorter programming time is beneficial as it reduces prolonged periods of time used for adjusting the stimulation settings, which can be stressful and tiring for the patient.

Since receiving CE Mark for the Vercise DBS System in 2012 as we reported, Boston Scientific has introduced a steady pace of innovation in the field of DBS, including the launch of the Vercise Gevia™ DBS System in 2017, which features the Vercise Cartesia Directional Lead. The Vercise Gevia DBS System provides patients with an unparalleled 25-year battery life.

The Vercise Deep Brain Stimulation (DBS) Systems are indicated for use in unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of levodopa-responsive Parkinson’s disease which is not adequately controlled with medication and for treatment of intractable primary and secondary Dystonia, for persons 7 years of age and older. Thalamic stimulation using the Boston Scientific Vercise DBS System is indicated for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.

Clinician comments

“DBS programming can be time intensive as a clinician works through trial and error to identify the right stimulation settings,” said Prof. Dr. Jens Volkmann, director and chairman of the Department of Neurology at the University Hospital of Wurzburg, Germany.

“We now have the ability–with STIMVIEW™ XT–to visualize lead placement in the patient to see how stimulation settings work in real time. This empowers clinicians to optimize therapy in a more efficient manner.”

Company comments

“Boston Scientific continues to advance Directional DBS with a strong cadence of meaningful innovation,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific.

“Vercise Neural Navigator 3 with STIMVIEW XT Technology is an example of how Boston Scientific translates technical complexity into an elegantly simple interface to empower clinicians to improve the lives of patients.”

Source: Boston Scientific Corporation

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