Boston Scientific receives CE Mark for the Vercise DBS System

14 September 2015 | News | By BioSpectrum Bureau

Boston Scientific receives CE Mark for the Vercise DBS System

The Vercise DBS System has both CE Mark and TGA (Australia Therapeutic Goods Administration) approval

The Vercise DBS System has both CE Mark and TGA (Australia Therapeutic Goods Administration) approval

Boston Scientific Corporation 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).

The Vercise DBS System is said to be 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.

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. 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.

"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. We believe this advanced technology can play a critical role in improving the lives of patients who suffer from these devastating conditions," said Mr Maulik Nanavaty, president, Neuromodulation, Boston Scientific.

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

 

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