Boston Scientific’s Vercise Genus DBS Earns FDA Approval

Boston Scientific’s fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System has achieved FDA approval. The portfolio, which was approved for conditional use during magnetic resonance imaging (MRI), is comprised of Bluetooth-enabled, rechargeable and non-rechargeable, implantable pulse generators (IPGs) to power directional leads.
 
DBS devices are able to treat the symptoms of Parkinson’s disease by delivering targeted electrical stimulation through surgically implanted leads in the brain attached to an IPG. They can be rechargeable or non-rechargeable depending on patient and clinician preference, but most are non-rechargeable.
 
“We have used the Vercise Gevia System with the Cartesia Directional Leads to provide our patients with a small device, a battery life of at least 15 years and optimal symptom control by delivering the right dose of stimulation precisely where it’s needed,” Jill Ostrem, medical director and division chief, University of California, San Francisco Movement Disorders and Neuromodulation Center said in a press release. “Now, the latest generation Genus portfolio – with an MR-compatible non-rechargeable IPG as well – provides greater access to patients who might not be candidates for a rechargeable system.”
 
The fourth generation Vercise Genus boasts improved battery longevity, directionality, and simulation capabilities. A collaboration with Brainlab offers enhanced visualization to see lead placement in the context of the patient’s segmented targeted anatomy.
 
“We continue to prioritize therapy innovations that improve our patients’ quality of life with a wide range of personalized offerings,” Maulik Nanavaty, Boston Scientific’s senior VP and president, Neuromodulation, told the press. “For people living with movement disorders, this means developing new technologies that are designed to refine motor control, reduce programming times and expand MR compatibility to improve their treatment experience and ultimately their daily living.”
 
Vercise Genus was launched in Europe last September and the company expects a controlled U.S. release to begin in the coming months.