Boston Scientific Receives FDA Approval for WaveWriter Alpha Spinal Cord Stimulator Systems

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) Systems. The portfolio, consisting of four MRI conditional, Bluetooth-enabled implantable pulse generators (IPGs), offers expanded personalization based on patient needs, including rechargeable and non-rechargeable options, and access to waveforms that can cover multiple areas of pain.

Chronic pain, defined as continuous and long-term pain lasting more than six months, impacts more than 50 million people in the U.S. and is the chief cause of disability in American adults. SCS therapies provide pain relief by delivering pulses of mild electric current to the spinal cord to interrupt pain signals traveling to the brain.

“We are excited by this earlier-than-anticipated FDA approval for the WaveWriter Alpha SCS Systems which will provide patients with multiple therapy options,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “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.”

Boston Scientific announced the European launch of the WaveWriter Alpha SCS Systems in September 2020. The company expects to commence the U.S. commercial launch during the first half of 2021.