Boston Scientific’s DBS System Gets FDA’s Clearance


Date: 01.02.2021

Boston Scientific Corporation BSX recently announced the receipt of the FDA’s approval for its fourth-generation Vercise Genus Deep Brain Stimulation (“DBS”) System. Notably, the DBS portfolio is approved for conditional use in a magnetic resonance ("MR") imaging environment. It also consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, implantable pulse generators (IPGs) that power Cartesia Directional Leads, which provide optimal symptom relief.

For investors’ note, the company had announced the receipt of the CE Mark and the subsequent limited-market launch of its fourth-generation Vercise Genus DBS System in Europe in September 2020. Boston Scientific also expects to begin a controlled U.S. launch in the upcoming months.

With the latest regulatory clearance and subsequent limited launch, Boston Scientific aims to strengthen its Neuromodulation business across the globe. Notably, the Neuromodulation business is a component of the company’s broader Rhythm and Neuro arm.

Per estimates, more than 10 million people worldwide are suffering from PD. The Vercise Genus System can treat the symptoms of PD by delivering targeted electrical stimulation through surgically implanted leads in the brain which are connected to an IPG. Per a field expert, the latest generation Genus portfolio, which has a MR-compatible non-rechargeable IPG, is expected to provide greater access to patients who might not be eligible for a rechargeable system.

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.


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