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Boston Scientific gains FDA nod for SCS

Boston Scientific announced Friday that it received approval for its WaveWriter Alpha spinal cord stimulator systems.

Marlborough, Mass.-based Boston Scientific’s WaveWriter Alpha portfolio of SCS systems includes four MRI-conditional, Bluetooth-enabled implantable pulse generators to expand personalization based on patient needs, including rechargeable and non-rechargeable options as well as coverage for multiple areas of pain, according to a news release.

The company touts the system as the only SCS portfolio that can layer paraesthesia and paraesthesia-free options simultaneously, supporting up to 32 contacts targeting specific nerves along the spinal cord. The Bluetooth capabilities allow fast programming while keeping 10 feet of distance between the programmer and the patient.

In September, Boston Scientific launched the WaveWriter Alpha portfolio in Europe after garnering CE Mark approval for managing chronic intractable pain and peripheral nerve stimulation of the trunk for pain management.

“We are excited by this earlier-than-anticipated FDA approval for the WaveWriter Alpha SCS systems, which will provide patients with multiple therapy options,” Boston Scientific senior VP & president of neuromodulation Maulik Nanavaty said in the release. “We look forward to sharing additional details about how our portfolio of SCS devices will usher in a new era of personalization in the treatment of chronic pain during the North American Neuromodulation Society annual meeting.”

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