Boston Scientific (NYSE:BSX) said today that it won CE Mark approval to market its Vercise deep-brain stimulation device to treat essential tremor in the European Union.
Marlborough, Mass.-based Boston Scientific said the Vercise device features "neural targeting" designed to allow physicians to tailor therapy to individual patients and a rechargeable battery that lasts as long as 25 years.
The Vercise device is already approved in Europe for treating Parkinson’s disease and dystonia.
"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," neuromodulation president Maulik Nanavaty said in prepared remarks. "We believe this advanced technology can play a critical role in improving the lives of patients who suffer from these devastating conditions."
"Essential tremor can be very debilitating for patients in their day-to-day activities such as writing and eating," added Dr. Veerle Visser Vandewalle, who along with Dr. Lars Timmermann was part of the team at the University Hospital Cologne that performed some of the 1st Vercise implantations. "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," Timmermann said. "The 25 year battery life may also help reduce the frequency of surgical interventions to replace depleted batteries."
Last year Boston Scientific launched a U.S. clinical trial of the Vercise device for treating Parkinson’s, with the 1st patient receiving the device at Cedars-Sinai hospital in Los Angeles.
