Boston Scientific Secures FDA Approval to Expand Indication for WaveWriter Alpha™ Spinal Cord Stimulator to Treat Painful Diabetic Peripheral Neuropathy

Oct 15, 2023 00:01 CST Updated 00:01

Boston Scientific

Medical Device Manufacturer

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October 11, 2023Boston Scientific Corporation Announces FDA Approval of WaveWriterExpanded Indications for the Alpha™ Spinal Cord Stimulator (SCS) System for the Treatment of Painful Diabetic Peripheral Neuropathy (DPN), a Complication of Diabetes that Can Affect the Health of the Lower Limbs.

#UnderstandingDiabetic Peripheral Neuropathy (DPN)

Diabetic neuropathy is one of the most common chronic complications of diabetes, which can affect both the central and peripheral nervous systems, and more oftenAffect the nerves in the legs and feet.Over time, high blood sugar (glucose) can damage these nerves and lead to pain and numbness in the legs, feet, and hands.

Among 37.3 million American diabetes patients (11.3% of the U.S. population), diabetic neuropathy will affect approximately 50% of adult diabetes patients.For pain management, there are only a few limited alternatives, including analgesic medications,But in recent years, due to the side effects of opioid painkillers being magnified, more and more people are choosing device-based pain management therapies.

#WaveWriter Alpha Spinal Cord Stimulation System

As a non-opioid treatment option, the WaveWriter Alpha Spinal Cord Stimulation System is used for chronic intractable pain in the lower limbs associated with DPN.This system provides a pain relief treatment by sending mild electrical pulses to the spinal cord to block pain signals transmitted to the brain.

The pain therapy of SCS is often divided into two types: one replaces pain with a tingling sensation, and the other blocks pain signals using stimulation that the patient cannot feel. The WaveWriter Alpha SCS system can provide both types of therapy for patients and also supports a combination of the two for pain treatment.

WaveWriter Alpha SCS hasBoston Scientific's Unique CreationNo Sting FAST™Therapy (Rapid Subconscious Therapy),Designed to provide immediate pain relief. The system supports full-body MRI scans under certain conditions, offering a total of four models in rechargeable or battery versions, and is equipped with the Cognita™ Solutions digital toolkit.

WaveWriter Alpha SCS System Received FDA Approval in December 2020 for the Treatment of Trunk and/or LimbsChronic refractory pain, including back-relatedUnilateral or bilateral pain associated with failed back surgery syndrome, complex regional pain syndrome type I and II, refractory low back painPain and leg pain.This approval expands the indication to include sensory abnormalities caused by lower limb DPN.

"Using spinal cord stimulation to support people with diabetes, one of the fastest-growing chronic diseases in the world, is an important advancement," said Jim Cassidy, President of Neurostimulation at Boston Scientific Corporation. "This expanded indication once again demonstrates our commitment to providing a robust portfolio of interventional pain solutions, offering physicians more treatment options to help their patients find relief."

# Recent Developments in Neuromodulation Business

On September 19, 2023, Boston Scientific Corporation announced that it had reached a definitive agreement to acquire Relievant Medsystems, Inc. The transaction includes an upfront cash payment of $850 million (approximately 6.2 billion RMB), as well as undisclosed milestone payments based on sales performance over the next three years.

Relievant Medsystems, Inc. is a medical technology company focused on diagnostic and therapeutic solutions for spine-related lower back pain.Its developed Intracept is the only device approved by the FDA for the treatment of chronic vertebrogenic low back pain.. Boston Scientific's acquisition this time aims to expand the neuromodulation product portfolio, offering more treatment options for patients with chronic low back pain.

Boston Scientific Corporation expects to complete the transaction in the first half of 2024, subject to customary closing conditions.

# About Boston Scientific

Boston Scientific was founded in 1979, with its headquarters in Natick, Massachusetts, USA. It is a global leading medical technology company. In 1997, Boston Scientific entered China, establishing branch offices and research centers in Beijing, Shanghai, and Guangzhou, with its China headquarters located in Shanghai. Boston Scientific has more than 17,000 products and has been granted over 16,000 authorized patents worldwide. In May 1992, Boston Scientific successfully went public on the New York Stock Exchange. In 2013, Boston Scientific's R&D investment reached 861 million US dollars, making it one of the medical device companies with the highest R&D investment globally.

On July 27, 2023, Boston Scientific announced its financial report for the second quarter of 2023. The report showed that the company achieved net sales of $3.599 billion (approximately RMB 25.816 billion) in the second quarter, an increase of 11.0% year-over-year, surpassing the company’s expected range. The GAAP net profit attributable to Boston Scientific Corporation’s common shareholders was $261 million (approximately RMB 1.872 billion), representing a 6.1% increase from $246 million in the same period last year.

Its neuromodulation business revenue in the second quarter of 2023 was $244 million, which was relatively small compared to other business segments and also showed a slower growth rate.In the global market, Boston Scientific is one of the three giants in neuromodulation, with competitors including Medtronic, Abbott, and LivaNova.

As for the acquisition of Relievant Medsystems, it is expected to provide a positive boost to Boston Scientific's business growth. Analysts noted that if Relievant’s sales increase from approximately $70 million in 2023 to around $200 million by 2026, this acquisition will add about 60 basis points to Boston Scientific's organic growth during 2025-2026.

Editor-in-Chief | Zhao Qing Reviewed by | Yi He Typeset by | Miya