Vercise DBS System receives CE Mark approval for treatment of essential tremor

Boston Scientific Corporation (NYSE: BSX) has received CE Mark for the Vercise™ Deep Brain Stimulation (DBS) System for the treatment of tremor, including the most common form of this movement disorder known as essential tremor (ET). Tremor is characterized by involuntary and rhythmic shaking, usually associated with difficulty in an activity such as writing or holding and controlling items.

Experts say ET may be as much as 20 times more prevalent than Parkinson's disease. The Vercise DBS System is the first system designed to offer precise neural targeting, allowing physicians to customize therapy for patients with ET. It also features a rechargeable battery that can last up to 25 years.

One of the first commercial implantations of the Vercise DBS System for ET was performed at the University Hospital Cologne, Germany, by a team of physicians, led by Prof. Dr. Veerle Visser Vandewalle, Head of the Department of Stereotaxy and Functional Neurosurgery, and Prof. Dr. Lars Timmermann, neurologist and professor of Neurological Movement Disorders.

"Essential tremor can be very debilitating for patients in their day-to-day activities such as writing and eating," said Prof. Dr. Vandewalle. "The Vercise DBS System provides advanced tremor care through precise neural targeting that is designed to manage ET symptoms effectively and improve patient quality of life."

"The Vercise DBS system features multiple independent current control, which gives clinicians the ability to control stimulation precisely for a neural target to help minimize unwanted side effects," said Prof. Dr. Timmermann. "The 25 year battery life may also help reduce the frequency of surgical interventions to replace depleted batteries."

ET can be a progressive disorder, typically starting on one side of the body, and then gradually affecting both sides. It is most commonly seen in older adults, however the onset of symptoms may occur at any age.² The exact cause for ET is unknown, but it is found to be mostly hereditary, where children of a parent who has ET have a 50 percent chance of inheriting the condition.²

"With the launch of the Vercise DBS System for the treatment of patients with Parkinson's disease in 2012, for dystonia in 2013, and now for tremor, Boston Scientific continues to demonstrate its commitment to provide more access to DBS therapy to more patients," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "We believe this advanced technology can play a critical role in improving the lives of patients who suffer from these devastating conditions."

Boston Scientific is an innovation leader in implantable DBS technology. The Vercise DBS System has both CE Mark and TGA (Australia Therapeutic Goods Administration) approval for the treatment of Parkinson's disease. It also has CE Mark for intractable primary and secondary dystonia, and is available for sale in Europe, Israel, Australia and select countries in Latin America.

In the U.S., the Vercise DBS System is investigational and not available for use or sale. The INTREPID clinical trial began enrollment in the U.S. in mid-2013 to evaluate the safety and effectiveness of the Vercise DBS System for the treatment of Parkinson's disease.