MARLBOROUGH, Mass., December 2, 2020 – Boston Scientific (NYSE: BSX) 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,[i] 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.[ii] 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.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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[i] The WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems provide safe access to full-body 1.5T MRI scans when used with specific components and exposed to the MRI environment under the defined conditions in the ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
[ii] Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education and research. Washington, DC: National Academies Press, 2011.