Medical company Boston Scientific Corporation (NYSE: BSX) reported on Friday the receipt of approval from the US Food and Drug Administration (FDA) for its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson's disease (PD), a progressive, neurodegenerative disorder.
The company added that the system is indicated for use in the bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa–responsive PD that are not adequately controlled with medication.
Approved for conditional use in magnetic resonance imaging (MRI), the company's portfolio consists of Bluetooth-enabled, rechargeable and non-rechargeable, implantable pulse generators (IPGs) that power Cartesia Directional Leads, which provides optimal symptom relief.
According to the company, DBS devices and the Vercise Genus System can treat the symptoms of PD by delivering targeted electrical stimulation via surgically-implanted leads in the brain connected to an IPG. The fourth generation Vercise Genus builds upon rapid and meaningful innovations in battery longevity, directionality and stimulation capabilities.
In 2020, the company commenced the European launch of the Vercise Genus System and expects to begin a controlled US launch in the coming months.
CVS Health expands GLP-1 weight management access through integrated care offering
Adyen to provide LillyDirect with payment technology services
Sanofi's MenQuadfi receives EU approval for infants from six weeks
Acurx receives FDA guidance supporting ibezapolstat Phase 3 development strategy
Zai Lab's zoci receives FDA orphan designation for neuroendocrine carcinomas
Biocon launches Yesafili biosimilar in US ophthalmology market
Ractigen Therapeutics IND application for RAG-1C receives FDA clearance
Pfizer reports positive Phase 3 results for LITFULO in nonsegmental vitiligo