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Boston Scientific's (BSX) DBS System Gets FDA's Clearance

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Boston Scientific Corporation (BSX - Free Report) 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.

Few Word on the Vercise Genus

The Vercise Genus DBS System, which is the fourth generation of the DBS system and has been in the market since 2012, is indicated for use in the bilateral stimulation of the subthalamic nucleus as an adjunctive therapy in reducing some of the symptoms of moderate-to-advanced levodopa-responsive Parkinson's disease (“PD”), which cannot be adequately controlled via medication. For investors’ note, PD is a progressive neurodegenerative disorder which causes stiffness, slowness and tremors due to a decrease of dopamine in the brain.

Boston Scientific’s collaboration with Brainlab enables the former to utilize the latter’s platform to provide enhanced visualization capabilities, thus aiding clinicians to see lead placement in patient's segmented target anatomy.

Significance of the Approval

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.

Industry Prospects

Per a report by Grand View Research, the global DBS-devices market size was valued at $1 billion in 2019 and is anticipated to expand at a CAGR of 9.6% between 2020 and 2027. Factors like rising patient population suffering from involuntary movements associated with dystonia and PD, and growing adoption of minimally invasive procedures, are likely to drive the market.

Given the market potential, the regulatory approval is expected to significantly boost Boston Scientific’s Neuromodulation business.

Recent Developments in Rhythm and Neuro Arm

The company, this month, announced a limited market release of the WaveWriter Alpha portfolio of Spinal Cord Stimulator (“SCS”) systems. Notably, the company received the FDA’s approval for the same in December 2020.

The company, in September 2020, signed an investment agreement with an exclusive option to acquire Farapulse, Inc, a privately held company developing a pulsed field ablation system. The same month, Boston Scientific announced the European launch of the WaveWriter Alpha portfolio of SCS Systems.

Comparison With Peers

With respect to the Neuromodulation business, Boston Scientific’s peer Abbott Laboratories (ABT - Free Report) , this month, announced the upcoming launch of its NeuroSphere myPath. It is a digital health app designed to track and report on patient perceived pain relief and general well-being associated with SCS or dorsal root ganglion therapy.

Another key player in the DBS therapy, Medtronic plc (MDT - Free Report) , announced the first enrollment in ADAPT-PD (Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease) this month. Notably, ADAPT-PD is in its trial, for evaluation of the safety and efficacy of adaptive DBS (aDBS) in patients with PD.

Integer Holdings Corporation (ITGR - Free Report) is another renowned name in the Neuromodulation business. Although the company reported decline in sales of Neuromodulation products due to the pandemic-led business disruptions, Integer Holdings expects to witness a recovery in its profit margin as the sales volume rebounds.

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