Boston Scientific Launches Spinal Cord Stimulator Systems in Europe

Boston Scientific has announced the European launch of the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) Systems. The portfolio, consisting of four MRI conditional¹, 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 impacts approximately 100 million people across Europe.^2,3 SCS therapies provide pain relief by delivering pulses of mild electric current to the spinal cord to interrupt pain signals traveling to the brain. The WaveWriter Alpha SCS Systems received the CE Mark and are indicated as an aid in the management of chronic intractable pain. They are also indicated for peripheral nerve stimulation of the trunk for pain management.
 
The systems feature combination therapy, the only SCS portfolio that has the ability to layer paraesthesia and paraesthesia-free options simultaneously, and support up to 32 contacts that target specific nerves along the spinal cord to meet the personal pain relief coverage needs of the individual patient. The Bluetooth platform enables faster programming that can be done while maintaining a typical physical distance of 10 feet between the programmer and the patient.
 
“Being able to offer my patients different therapy options is important because it provides them with pain relief that can maintain long-term results,” said Jan Vesper, M.D. Ph.D., Department of Functional Neurosurgery and Stereotaxy at the University Hospital of Düsseldorf, Germany. “The combination of different therapy features that promote simplicity like the WaveWriter Alpha SCS Systems enable enhanced personalization in the advanced treatment of chronic pain.”
 
Trial Results
The COMBO randomized control trial, which compared the effectiveness of SCS with multiple modalities to conventional SCS in patients with chronic pain, found 88% of patients were responders with multiple modalities, which is defined as patients achieving 50% or greater pain relief compared to baseline. Patients also realized a significant 26-point improvement in functional disability⁴ where many patients who were “severely” or “moderately disabled” were able to return to many of their daily activities.⁵ Multiple Level 1 RCTs and real-world studies support the design of Boston Scientific’s SCS therapy.^6,7,8,9,10 
 
“The launch of the WaveWriter Alpha SCS Systems in Europe represents a significant step forward in the treatment of chronic pain,” commented Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “By unifying our portfolio of SCS devices and offering the latest therapy advances, we remain committed to advancing meaningful innovation, providing both physicians and patients access to the full benefits of our entire portfolio of devices.”
 
The WaveWriter Alpha SCS Systems are not available for use or sale in the United States.
 
References:
^1. 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
^2. Mills S et al. Identification and Management of Chronic Pain in Primary Care: A Review of Current Psychiatry Reports. 2016.
^3. Policy Connect. About Chronic Pain. https://www.policyconnect.org.uk/cppc/about-chronic-pain Accessed March 2012
^4. Oswestry Disability Index
^5. Wallace M et al. Outcomes of a Prospective Randomized Controlled Trial Utilizing a Spinal Cord System Capable of Multiple Neurostimulative Modalities (COMBO). NANS Annual Meeting. January 2020.
^6. Thomson, Simon et al. Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial. Neuromodulation, January 2018.
^7. North J et al. Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects. Neuromodulation. January 2020.
^8. Metzger C et al. Pain Relief Outcomes Using an SCS Device Capable of Delivering Combination Therapy with Advanced Waveforms and Field Shapes. Expert Rev Med Devices. September 2020.
^9. Veizi E et al. Spinal Cord Stimulation (SCS) with Anatomically Guided (3D) Neural Targeting Shows Superior Chronic Axial Low Back Pain Relief Compared to Traditional SCS-LUMINA Study. Pain Med. November 2018.
^10. Paz et al. HALO Study: Exploration of High and Low Frequency Outcomes in Sub-p (n=30), INS 2019