MRI Interventions and Brainlab AG have announced the first two cases performed in Europe with the ClearPoint Neuro Intervention System.
Stephan Chabardes, Universite Joseph Fourier (UJF) Hospital in Grenoble, France, used the ClearPoint system to assist with the implantation of deep brain stimulation (DBS) leads in two patients suffering from Parkinson’s disease. In addition to being the first ClearPoint commercial cases in Europe, the cases carried the historical significance of being performed at the location where DBS treatment was originally developed.
The traditional surgical technique for implanting DBS leads has been performed without intra-procedural visualidation, meaning that the surgeon cannot see the neurological target and surgical devices inside the brain while the procedure is being performed. By contrast, the next generation ClearPoint system provides surgeons with direct, real-time visualidation of the patient’s anatomy and the surgical devices throughout the procedure. Using the ClearPoint system, the surgeon sees and selects the neurological target, aims the ClearPoint targeting device, and watches via magnetic resonance imaging (MRI) as the surgical tool is advanced to the target.
“The cases went well and we are very pleased to have performed the first ClearPoint procedures in Europe,” said Chabardes. “The move to real-time, MRI-guidance for minimally invasive neurosurgical procedures is inevitable and the ClearPoint system is now bringing these capabilities to the clinic.”
“We are very pleased to formally launch our European ClearPoint commercialisation effort with initial cases in Grenoble, a significant site to neurosurgeons and their patients around the world for its role in pioneering DBS therapy,” said Kimble Jenkins, CEO of MRI Interventions. “This activity in Europe builds on the growth we are seeing in the United States, where ClearPoint systems have already been installed in 16 sites.”
In June 2010, the ClearPoint system received 510(k) FDA clearance for general neurological interventional procedures. The system was CE-marked in February 2011.