New Hope From Innovation in Chronic Pain Management

Marlborough, Massachusetts-based Boston Scientific Corporation has made great strides in recent months on their WaveWriter Alpha™ line of spinal cord stimulators (SCS). We reported in October 2020 on Boston Scientific’s launch of the devices in the European market. Later in 2020, the same devices received FDA approval, enabling the company to launch the portfolio in the U.S., which it announced in mid-January 2021.

The WaveWriter Alpha portfolio includes four different implantable pulse generators (IPGs). Rechargeable and non-rechargeable versions are available with either 16 or 32 leads. Deciding between rechargeable and non-rechargeable IPGs depends on a few factors, including the frequency and intensity of the prescribed therapy. The lifespan of the rechargeable IPG is longer than the non-rechargeable, but comes with the inconvenience of regular charging sessions. Additionally, the entire portfolio is designed and approved for safe use of full-body MRI.

Boston Scientific developed new stimulation modalities to differentiate the WaveWriter Alpha from other traditional or more standard burst stimulation technologies. Through the company’s research, it has created what it calls FAST™. Fast-Acting Sub-perception Therapy (FAST) taps into a new mechanism of action that, like some other advanced stimulation modalities, does not produce paresthesia, and provides relief within minutes with no wash-in or wash-out period.

With fast relief, which equates to fewer office visits and insertion procedures, the success of the FAST mechanism is under continued investigation in the Paresthesia-Free Fast-Acting Sub-perception (FAST) Study with sites in South Carolina and Oregon.

The technology developed by Boston Scientific is fascinating, and gives us a glimpse at the future of pain relief.

In addition to the new stimulation therapy options with the WaveWriter Alpha, new technology in the devices allows for more convenient patient care and continual research opportunities. Remote monitoring allows specialists to track their patients’ use and quality-of-care.

New Pain Survey During COVID

A survey conducted in mid-2020, at the height of the COVID-19 pandemic, found that during the pandemic pain increased, on average, due in part to enforced postponements of elective procedures, the conception that doctor offices and healthcare facilities were unsafe, and feelings that the pain was bearable enough to wait out the threat of the pandemic.

Studies have also shown a connection between emotional pain and actual pain, which could explain that stress and the challenges of the pandemic actually increased perception of pain. The survey also uncovered a general lack of knowledge of non-opioid pain relief options, so patient that did seek help tended to not ask for spinal cord stimulation.

More Studies

OTW recently had the opportunity to speak with Nilesh Patel, M.D., who became the VP of Medical affairs at Boston Scientific in 2019. As a former specialist with over 25 years at the Cleveland Clinic, Patel has seen the progression made in spinal cord stimulation for pain relief over the last few decades. He has extensive experience providing pain relief with spinal cord stimulation and radiofrequency ablation techniques.

Patel has great expectations for the WaveWriter Alpha product line. Studies prior to launch showed significant pain reduction with 88% of patients achieving the typical endpoint of at least 50% pain reduction when treated with Spectra WaveWriter in the COMBO study.

Another study, the FAST PRO study, showed fast-acting sub-perception therapy (FAST) could reduce NRS pain scores from an average of 6.5 to 1.3 immediately after activating FAST during the programming session. Pain relief was maintained through 3- and 6-month follow-up visits with average NRS pain scores of 1.6 and 1.5 points, respectively. Results for both the survey and FAST study were presented at the North American Neuromodulation Society (NANS) 2021 meeting.

In addition to 3 level 1 randomized clinical trials, another 3 “real-world” studies investigated the effectiveness of spinal cord stimulation. The WaveWriter study reported that 61% of patients achieved an NRS of 2 or lower at the final follow up. The Halo study showed that effective pain relief (final NRS = 2.5) could be achieved using 88% less energy than 10kHz (high-frequency) therapy. Finally, the Lumina study showed clinically relevant pain relief (NRS <3) through 2 years of follow up.

Expanding on the interaction of the pandemic and pain, Patel explained that in the Envision study, which was conducted in partnership with IBM, found that patients responded differently to relief from the WaveWriter during the pandemic. Additionally, the new technology allowed the study investigators to compare pain and pain responses before and during the pandemic as well as intervene as pain changes.

Another exciting aspect of the ongoing studies is the investigation of biomarkers, such as data from wearables like sleep monitors, to develop artificial intelligence that will allow the WaveWriter Alpha to predict changes in pain, possibly even before they happen. As a simple example, the device may learn that a poor night’s sleep leads to increased pain the following day, and therefore knows to increase the intensity of the therapy. With enough data, even more complex scenarios could be possible in the future.

With increasing pressure on physicians to reduce opioid prescriptions alternatives are crucial for meeting the increasing pain relief needs of patients. Further, pain is experienced in many different ways thereby requiring different methods for pain relief.

“Ultimately,” says Patel, “the WaveWriter Alpha will usher in the next era of personalization in pain relief therapies.”