Sharp, intense, and shooting pain resulting from a malfunction in nervous system can be difficult to treat as it often does not respond to standard treatment. Living with chronic pain can be debilitating, but thanks to advances in medical technology, there are treatment options available that can control pain so that one can live life with ease and comfort. To manage the chronic pain, Boston Scientific has introduced WaveWriter Alpha Spinal Cord Simulator (SCS) systems, that feature largest four full body MRI, Bluetooth-enabled implant pulse generators (IPGs), including rechargeable and non-rechargeable options along with offering different types of functionalities to suit needs of the patient.

The implantable pulse generators (IPGs) are supported by Cognita™ Solutions suite of digital tools for patients and physicians. The Cognita™ Solutions address common challenges in pain management, help patients find local physicians, help physicians sustain functional outcomes for patients, and raise awareness about drug-free pain management options.

For the first time in Spinal Cord Stimulation, the WaveWriter Alpha Spinal Cord Simulator systems provide uncompromised personalization with Fast Acting Sub-Perception Therapy (FAST^TM) designed to deliver paraesthesia-free pain relief in minutes targeting a new and distinct SCS mechanism of action. The medical device works to relieve chronic pain by sending mild electric pulses to the spinal cord for interrupting pain signals navigating towards the brain. Specific targeting and stimulation parameters produce rapid and robust pain-relief. While Paraesthesia-based therapy works with a light tingling sensation, paraesthesia-free therapy works without that sensation, so the user does not experience any kind of discomfort while wearing the implantable devices. Boston’s Scientific proprietary FAST helps define clinical practices to optimize patient outcomes.

Approved by US Food and Drug Administration in December 2020, the WaveWriter Alpha SCS systems is a proven solution for the treatment of chronic pain that provides patients access to the convenient medical support required to live life pain-free. The WaveWriter Alpha SCS systems combines Vertiflex procedure and radiofrequency ablation to aid in the management of chronic intractable pain of the limbs, trunks, low back, leg, pain associated with failed surgery, and Complex Regional Pain Syndrome Types I and II.

The WaveWriter Alpha SCS system is best suited for people who :

• have shooting pain after undergoing back surgery

• are not considered ideal for conventional spine surgery

• do not find any results with conversative pain-relieving treatments

• have neuropathic type pain such as diabetic neuropathy, shingles pain (herpetic neuralgia), complex regional pain syndrome

• suffer from chemotherapy induced pain 

• neck or back pain radiating to arms or legs

No other medical device offers the type of stimulation that the cutting-edge WaveWriter Alpha SCS systems provide in the field of spinal cord stimulation. The system is touted as the only SCS portfolio to support up to 32 contacts targeting specific nerves along the spinal cord, which gives it a major competitive edge.

In Boston Scientific three-month Combining Mechanisms for Better Outcomes (COMBO), it was found that 88% of patients experienced outstanding results responding to therapy in several modalities whereas 50% noted decrease in pain severity with WaveWriter Alpha SCS systems. The clinical trial intended to compare the results of Boston’s WaveWriter platform with other platforms designed for “combination therapy” or multiple waveforms. The systems show excellent efficacy for the stimulation of peripheral nerves for reducing expressiveness of pain syndrome as well as improving the quality of life.  

The best part about the WaveWriter Alpha system is pain in different areas of the body can be treated all at once using the right kind of stimulation for each pain area, using a wireless remote control for adjusting the amount of stimulation as per the target area. Boston Scientific Personalized therapy is the first FDA-approved medical system to deliver both paraesthesia and paraesthesia-free therapies simultaneously.

As MedTech industry attempts to innovate in a stagnant neuromodulation industry, major key players in the industry players are looking to bounce back, rolling out new and improved medical systems.

Detailed Comparative Analysis of Boston Scientific WaveWriter Alpha SCS system

• Battery Life
  

Boston Scientific WaveWriter Alpha SCS system IPG rechargeable battery could provide at least five years and up to 25 years or more service. However, the battery life depends on the stimulation settings and conditions. Overtime, the IPG battery would require frequent charges as the repeated recharge cycles reduce maximum charging capacity. Abbott’s Proclaim XR neurostimulation system features a low-dose, recharge-free spinal cord stimulation system with 10-days battery life coupling low-energy therapy to provide chronic pain relief. Designed with BurstDR stimulation waveform technology, the system mimics natural patterns found in the brain and the low dose of mild electrical pulses extends system’s battery life. The neurostimulation system is the latest advancement in patient-centric therapy, which reduces the hassles of recharging frequently so that patients can live their life without having a constant reminder of undergoing treatment. The system is also compatible with Apple mobile devices and wireless Bluetooth technology.

Medtronic’s Intellis has an Overdrive™ battery technology, which is optimized for the increased energy demands of HD therapies for 9 years and 32,000 cycles. Whereas Stimwave Freedom have no battery implanted and is totally wireless, consisting only tiny leads that are inserted into the epidural space dorsal to the spinal cord. However, the external wearable battery of the stimulator has 3-8 hours of battery life.

• Personalization

Boston Scientific ushered the next era of personalization with Spectra WaveWriter, designed to personalize pain relief through combination therapy and waveform automation. Medtronic’s Intellis comes with AdaptiveStim technology that automatically adjusts the therapy according to patient moves. Thus, the system delivers a personalized treatment on the basis of seven unique body positions, allowing greater flexibility and comfort. Abbott recently received approval from FDA for the company’s Patient Controller app on compatible Apple smartphone devices to allows patients living with debilitating chronic pain to manage therapy directly from their smartphones. 

•  Convenience & Usabilit
  

The patients are required to always keep the remote control of Boston Spectra WaveWriter Alpha in hand and portable RF communications equipment require to be kept at a minimum distance of 6 inches from the implanted device. Nevro HF10 requires limited to no daily remote usage and one can leave it on 24/7 as it does not have any sleep restrictions. The device has a demonstrated success rate for chronic and back pain, providing significant relief to both the body parts. Nevro Senza® Omnia™ is the first and only spinal cord stimulation (SCS) system designed to deliver all SCS frequencies between 2 and 10,000 Hz. The system is programmed to provide most waveforms in a single product, solely or when paired with HF10. Unlike non-rechargeable systems, the Omnia system is designed to last over ten years and has conditional full body MRI approval. Also, the SCS system will be upgradable to future waveforms and frequencies. 

• Frequency
  

Boston Scientific WaveWriter can run both burst and tonic stimulation at the same time. With paresthesia-free stimulation, the patient does not feel any kind of tingling sensation while using the device, which is an added advantage over other neurostimulators for chronic pain available in the market. Precision Novi is capable of burst or 1.2KHz stimulation, but not recommended due to its decreased battery life, but it cannot do both at the same time. Medtronic Intellis can use low dose 40Hz or high dose 1000 Hz stimulation. Nevro Senza Omnia does not require mapping and can simultaneously run burst with high frequency or lower frequency.

Conclusion

While physicians have been utilizing neurostimulation for pain since decades, neurostimulation devices have been continuously evolving in the quest for offering robust pain relief without side-effects, and WaveWriter Alpha is a true example of the medical advancement. The newer SCS systems are now upgradeable, offer patients pain relief without eliciting paresthesia, a kind of tingling sensation used to cover up pain in SCS protocols and offer patients the option to control their stimulation from smartphone. Immersive virtual reality is likely to boost the effectiveness of spinal cord stimulation for chronic pain management as it will allow patients to see as well as feel the effects of electrical stimulation.

According to TechSci research report, “Global Spinal Cord Stimulation Devices Market By Product Type (Rechargeable v/s Non-Rechargeable) By Application (Failed Back Syndrome, Complex Regional Pain Syndrome, Degenerative Disk Disease, Unsuccessful Disk Surgery, Others) By End User (Hospitals & Clinics, Ambulatory Care Centers, Others) By Region, Competition Forecast & Opportunities, 2026”, the global spinal cord stimulation devices market is projected to grow at a significant rate during the forecast period on account of numerous instances of complex regional pain syndrome among population. Moreover, technological advancements in the devices is bringing forth more demand from the patients suffering from prolonged pain or pain due to failure of spinal surgeries, is driving the market growth of global spinal cord stimulation devices market.

According to another TechSci report, “Global MRI Market By Field Strength (High-Field MRI Systems (1.5t MRI Systems, 3t MRI Systems), Low-To-Mid-Field MRI Systems (<1.5t), Very-High-Field MRI Systems (4t and Above)), By Type (Fixed, Mobile), By Architecture (Closed MRI Systems, Open MRI Systems), By Application (Brain and Neurological, Oncology, Spine and Musculoskeletal, Abdominal, Cardiac, Others), By End User (Hospitals, Imaging Centres, Ambulatory Surgical Centres, Others), By Region, Forecast & Opportunities, 2026”, the global MRI market is expected to witness a CAGR of around 8% to reach a market value of USD9.4 million through 2026. Technological advancements that provide greater imaging possibilities with less harmful radiations and increasing patient pool suffering from neurological and musculoskeletal disorders are the some of the major factors contributing to the market growth.