Nerve Agents: A Look at the Neurostimulation Device Market

The memory is forever etched in Doug Evans’ mind.

For weeks, the seasoned medtech entrepreneur and 300-plus patent holder helplessly watched his son struggle to breathe independently. A mechanical ventilator was the boy’s sole lifeline, delivering the steady, automatic breaths his ailing body needed to sustain his fight against cancer.

Evans’ son continued to experience breathing difficulties even after mechanical ventilation was no longer needed. Like many patients who require artificial respiratory support, the 14-year-old had trouble weaning himself off the ventilator.

While mechanical ventilation (MV) is a life-saving treatment for various medical conditions, it can cause considerable structural and functional diaphragm changes, prompting muscle fiber atrophy and a notable decline in contractile force. The scientific name for such an outcome is ventilator-induced diaphragmatic dysfunction (VIDD), and research indicates it is a critical risk factor for numerous adverse clinical outcomes, such as prolonged ventilation, challenges in weaning from ventilation, extended ICU stays, and acute respiratory failure complications.¹ Studies have shown that 35% of MV patients fail to ease themselves off support within 90 days, 10% face overall difficulty weaning, and 9% experience prolonged weaning with a higher death rate.² Furthermore, diaphragm weakness was evident in up to 80% of patients with MV weaning difficulty, trial data demonstrate.

Evans’ son was among the 10% of patients with MV weaning difficulty. The teenager eventually freed himself from MV dependency, but died several weeks later, leaving his father heartbroken and convinced the prolonged ventilation contributed to his demise.

“Cameron did eventually wean off the ventilator, but he was never the same,” Evans recalled. “He passed away several weeks later, and I believe the cumulative effects of prolonged ventilation played a significant role.” 

Devastated by his son’s death, Evans channeled his grief into a relentless drive to improve outcomes for patients requiring mechanical ventilation. His determination to revolutionize critical care led him to the corner office at Lungpacer Medical Inc., a Simon Fraser University (British Columbia) spinout firm that developed a new, minimally invasive approach to diaphragm pacing. The company was founded in 2009 by Andy Hoffer, Ph.D., an SFU professor and entrepreneur who drew inspiration for the venture from a similar personal tragedy to Evans’.

The pair raised funding for proof of concept and clinical trials, and expanded the company’s product development team to craft a marketable solution. 

“My mother had pneumonia, was rushed to the hospital, put in intensive care, and right away was hooked up to a ventilator. Within a week, she was being coached to breathe again on her own, and she couldn’t,” Dr. Hoffer said in an online video. “About 20 to 30% of patients on mechanical ventilation fail to wean, and I think in many or most of them, it’s probably because the diaphragm has lost its strength and fatigues. When I came back from being with my mother, I had come up with the concept of a minimally invasive, simple, temporary way to pace the diaphragm. What we’re doing is keeping the diaphragm strong so it can start up again when you need it.”

Keeping the diaphragm strong is the basic principle behind Lungpacer’s core technology. The company’s AeroPace System uses a catheter fitted with 30 electrodes to deliver electrical stimulation through blood vessels near the right and left phrenic nerves. That neurostimulation array activates the diaphragm muscle in sedated or sleeping patients, preventing its weakening. Evans likens the solution to “going to the gym twice a day to rebuild strength.”

“Our AeroPace System is a sophisticated neuromodulation system, but integrated into a catheter-based platform like what clinicians already use every day and commonly in ventilated patients—central venous catheters,” explained Evans, Lungpacer’s president/CEO and former Kensey Nash Corporation COO. “Our engineers solved a fascinating challenge: they fit 30 individual electrodes in two arrays onto a standard-sized catheter, which means one device can simultaneously stimulate both left- and right-side phrenic nerves while accommodating virtually every patient, regardless of body size. That’s smart engineering. These electrodes don’t need to directly contact the phrenic nerves, they just need to be close enough to capture them.”

Such smart engineering has beget a plethora of clinical benefits: Studies have linked the AeroPace System to a 50% lower risk of tracheostomy, a 47% lower risk of re-intubation or reconnection, 74% greater diaphragm strength, 96% greater breathing efficiency, 43% faster MV weaning over 30 days, and 3.2 fewer days on MV in the ICU.

Further validation of Lungpacer’s neuromodulation technology came with its authorized emergency use during the COVID-19 pandemic. The decision to permit its use was based on bench testing and reported clinical evidence.

That evidence was also instrumental in persuading the U.S. Food and Drug Administration (FDA) to sanction the AeroPace System for commercialization in December 2024. The solution is approved to treat U.S. adults who have been on mechanical ventilation for at least 96 hours and have not successfully weaned. It is not suited for patients with active implanted cardiac pacemakers, defibrillators, or other implantable electronics within proximity to the neurostimulation catheter, since it has not been clinically evaluated for safety with these implanted electronic devices. 

The AeroPace System continued its regulatory ramp-up last summer with reimbursement approval from CMS. The agency’s New Technology Add-on Payment authorization allows for up to 65% remuneration of the additional cost for the technology; hospitals are now eligible to receive up to $23,650.90 in additional Medicare reimbursement per case with the AeroPace System.

“The longer patients stay on a ventilator, the higher their risk of death, infection, cognitive impairment, and prolonged complications they may carry for the rest of their lives. The economic burden is equally staggering,” Evans noted. “Ventilation-related care represents as much as $96 billion in annual direct healthcare spending, and ventilated patients cost the healthcare system roughly $5,000 to $6,000 per day.”

“We developed the first and only temporary transvenous diaphragm neurostimulation system, designed to rebuild diaphragm muscle strength during mechanical ventilation,” he continued. “We’re essentially tapping into nature’s way of breathing. This didn’t happen overnight. We spent more than 12 years in development, conducted rigorous randomized controlled trials, and earned FDA premarket approval. This kind of well-vetted, evidence-based expansion is why neurostimulation continues to grow into major therapeutic areas.”

That growth is being driven by rising healthcare spending, technological advancements, and escalating demand for personalized, non-pharmaceutical treatments. Along with an upsurge in applications and expansion of non-invasive solutions, these dynamics are set to push the global neurostimulation market into double-digit value over the next seven years. Grand View Research projects the sector’s total worth to swell 10.3% annually, going from $6.37 billion in 2025 to $13.93 billion in 2033.

Expanding research into brain-computer interfaces, deep brain stimulation, and transcranial magnetic stimulation will likely create promising new therapeutic areas within the market as patients and clinicians seek ways to restore lost functional autonomy and boost overall quality of life.

“We are seeing strong growth in chronic pain, epilepsy, tinnitus, and urinary incontinence, driven by unmet clinical need and increasing acceptance of neuromodulation as a long-term therapy alternative,” observed Grant Harbo, technical sales engineer at Nissha Medical Technologies, a Buffalo, N.Y.-based business unit and wholly owned subsidiary of Nissha Co. Ltd. The unit designs, develops, and manufactures single-use medical technologies. “These indications are especially well-suited to wearable and peripheral stimulation approaches that lower procedural risk and expand patient eligibility. Breakthroughs in advanced materials, new power sources, and continued miniaturization will significantly expand what neurostimulation devices can achieve.”

Those future milestones will likely be notable, based on the technology’s accomplishments to date: Commercial solutions are helping patients manage their persistent pain, mental health, chronic disease, and neurological disorders (Parkinson’s and epilepsy).

NeuroPace Inc. is targeting the latter condition with its Responsive Neuro System (RNS), a brain-responsive neurostimulation tool built to prevent epileptic seizures at their source. The system consists of a small neurostimulator connected to wires (leads) that are implanted in up to two seizure onset areas in the brain. The device continuously monitors brain activity to detect abnormal patterns and delivers mild electrical pulses to interrupt anomalous activity and prevent a seizure. 

The RNS System received FDA approval in 2013 for adults with partial-onset seizures that are not controlled by medication. NeuroPace filed a Premarket Approval Supplement application with the agency last December to expand the product’s indication to include patients with anti-seizure medication-resistant idiopathic generalized epilepsy with generalized tonic-clonic seizures.

By filing the premarket approval application, NeuroPace is seeking to strengthen its presence in a sector dominated by LivaNova and Medtronic, the latter of which considers itself the leading market player. The company’s deep brain stimulation (DBS) technology is approved for Parkinson’s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy, and has been implanted in more than 180,000 patients—reportedly the highest total among competing DBS systems.

Medtronic reinforced its leading market status last winter with CE mark and FDA approvals of its BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier for Parkinson’s disease. Named one of TIME magazine’s best inventions of 2025, Medtronic’s aDBS senses brain signals linked to Parkinson’s motor symptoms and adjusts the stimulation in real time in response to those signals. That dynamic adaptability, TIME proclaims, provides “just the right stimulation to reduce tremors.”

“Neurostimulation devices are increasingly incorporating personalized therapy settings and closed-loop control, allowing stimulation parameters to be tailored to individual patient physiology,” Harbo observed.

Clearly, Medtronic is likely to maintain its DBS market reign in the near term, but its competitors are steadily gaining ground with their own approaches to personalized therapy.

Aleva Neurotherapeutics’ directSTIM system, for example, alleviates symptoms of Parkinson’s disease and essential tremor through proprietary directional electrode technology, which has proven more precise and efficient than current multidirectional methods. The directSTIM leads feature four tiers of three independent, rounded contacts at the distal end, along with four segmented levels that deliver full 360-degree directional stimulation via 12 fully independent contacts per lead.

The leads’ design enables physicians to precisely control the stimulation field’s direction and shape, thereby personalizing the therapy and helping patients avoid side effects despite impedance variability. 

Aleva Therapeutics’ directSTIM system is approved in Europe and gained the FDA’s blessing four years ago to conduct an Investigational Device Exemption (IDE) study in the United States. The product, however, has not yet been authorized for U.S. sale.

“…we are fully committed to providing the benefits of our truly directional DBS system to U.S. patients and the community of neuroloists and neurosurgeons,” Aleva Therapeutics CEO Stefano Alfonsi said upon receiving the IDE study approval. “The North American DBS market is definitely the largest in volume and turnover, and we are convinced the innovation provided by directSTIM, combined with our vision, will make a dent in this space.”

Maybe so, but that dent will need to be substantial to offset the impact from rival solutions.

Abbott’s Infinity DBS system, for one, could be difficult to eclipse—like Aleva’s directSTIM platform, the product features directional leads (albeit not rounded) but has provided symptom relief to U.S. Parkinson’s and essential tremor patients for the past decade. In 2020, the Infinity system received an expanded FDA indication to target the internal globus pallidus, a part of the brain that plays an integral role in motor function. With that authorization, Infinity became the first and only directional platform approved across all major targets for treating movement disorders, Parkinson’s disease, and essential tremor.

Infinity was also the first and only DBS system for those indications to incorporate an iOS software platform using Bluetooth wireless technology. The platform enables clinicians to streamline the programming process with an iPad mini device (using Abbott’s Informity Programming tool) and helps patients to discreetly manage their symptoms with an Infinity DBS System iPod touch controller.

The Infinity system can be programmed remotely through Abbott’s NeuroSphere Virtual Clinic, which allows patients to adjust their stimulation therapy in real time without an in-office visit. Moreover, the NeuroSphere Digital Health app offers on-demand support tools, a comprehensive education library, and guided tutorial videos to help simplify therapy management. The Virtual Clinic earned a spot on TIME magazine’s best inventions list in 2021 and received the Biotech Breakthrough Award in 2022.

“Abbott’s proprietary NeuroSphere Digital Health platform and updated Digital Health app allow patients to engage with their healthcare providers from anywhere* and are inclusive of the NeuroSphere Virtual Clinic, the only connected care technology in the U.S. for people who have neuromodulation systems,” noted Rebecca Wilkins, divisional vice president, R&D, Abbott Neuromodulation Division. “NeuroSphere Virtual Clinic can be used to adjust treatment settings for both people living with chronic pain and movement disorders. Those in need of treatment already face significant hurdles to receive care because of time, distance, or an inability to find someone who can effectively diagnose and treat their chronic condition. The goal of advanced connected care technology is to break down those barriers. Communication between people and their doctors is critical to ensuring exceptional care, especially for those who suffer from chronic conditions that can benefit from stimulation therapy.”

Indeed, effective communication is critical to exceptional patient care, but technological agility and ambient intelligence are important as well. Abbott’s Liberta RC DBS system, for example, boasts the longest-lasting battery charge and smallest DBS implantable pulse generator (IPG) on the market, according to the company.  

 Roughly the height and width of a smartwatch face, the Liberta RC DBS system is about 31% smaller than other commonly used implantable, rechargeable DBS devices in the United States. Under standard settings, the system needs recharging as few as every 37 days (10 times annually) using a wireless charger placed over the device. For those who prefer a weekly charging schedule, only 30 minutes of charging is needed. The wireless charging system allows people to be active while wearing it and can fully recharge the Liberta RC DBS system twice before it must be plugged in again. The system can be controlled on an Abbott-supplied patient controller or a compatible, secure iOS device and offers users helpful notifications as well as customizable settings for a personalized charging experience.

“Our focus is to create technology that fits into a person’s life as seamlessly as possible. From an engineering perspective, this often means we must make trade-offs,” Wilkins said. “Several years ago, we introduced neurostimulation devices that didn’t have to be recharged because we knew that charging the system took a significant amount of time out of people’s lives. When we decided we wanted to make an even smaller implantable pulse generator to meet the needs of people who have smaller frames or just need a smaller device, we knew that—as a tradeoff—the system would need to be rechargeable. Instead of settling for the status quo and expecting people to recharge their devices every day or week, we chose to completely rethink what was possible when it came to how long a battery should last between charges. Because of this, we now have the only rechargeable neuromodulation systems in which people can go several weeks between charges, which means they spend less time managing their condition.”

Parkinson’s patients using Boston Scientific Corp.’s Vercise DBS system spend less time managing their condition, too. Available in Europe since 2012 and the United States since 2017, the system operates in tandem with the Brainlab platform to offer enhanced real-time visualization and stimulation of patients’ unique anatomies.

Three summers ago, the company received FDA approval for the Vercise Neural Navigator 5 Software with STIMVIEW XT Technology, which it developed with Brainlab. The software includes an enhanced user interface that displays patient data in a simplified format and gives clinicians access to advanced settings for increased therapy delivery. 

The Vercise Genus DBS platform features Bluetooth-enabled IPGs that power 16-contact Cartesia Directional Leads, which enable greater programming flexibility. The Vercise Genus R16 has a rechargeable battery lasting 15 years, while Vercise Genus P16 is non-rechargeable and lasts three to five years.

The Genus lineup also incorporates Boston Scientific’s proprietary Illumina 3D technology, a tool that leverages intelligent algorithms to automatically create a patient-specific stimulation plan for streamlined, simple DBS programming.

“We’re seeing real momentum around personalization,” stated Jim Cassidy, senior vice president/president, Neuromodulation at Boston Scientific. “Our Illumina 3D algorithm coupled with our image-guided technology, creates a patient-specific anatomical model that gives clinicians a clearer view of each patient’s brain anatomy, for targeted lead placement and a tailored programming strategy. When you pair that with our Cartesia X and HX directional leads, physicians can shape stimulation with a highly personalized approach, steering current to the areas that need treatment while avoiding nearby structures associated with side effects.”

Boston Scientific also offers a personalized approach to chronic pain management. Its WaveWriter Alpha Spinal Cord Stimulation system offers both 16- and 32-contact generators in both rechargeable and primary cell options to deliver electrical current to the spinal cord’s dorsal columns. FAST is the newest addition to the Boston Scientific programming platform. The concept is to provide a rapid onset of pain relief using multiple central points of stimulation activated by a symmetrical biphasic waveform. 

WaveWriter Alpha features FAST and Optimized Contour Therapy offerings. FAST is designed to provide profound paresthesia -free pain relief in minutes using multiple central stimulation points activated by a symmetrical biphasic waveform; Contour Therapy delivers broad paresthesia-free coverage using less energy than conventional paresthesia-free therapies.

Boston Scientific augmented its chronic pain offerings last fall with the $533 million purchase of its remaining equity in Nalu Medical Inc., whose FDA-cleared miniaturized neurostimulation implant includes a thin electrical lead that reportedly lasts 18 years. The company had been an investor in Nalu Medical since 2017.

“Chronic pain remains one of the most prevalent and costly health issues we face as a society. Peripheral nerve stimulation is a relatively small market today but poised for expansion as awareness grows about its ability to address underserved patients,” Cassidy told MPO. “Our recent acquisition of Nalu Medical reflects that opportunity, and with technologies like Nalu’s micro-IPG in our portfolio, we see clear potential to help clinicians treat more patients with targeted, less invasive therapies.”

“Our priority is to focus on the unmet needs of patients with chronic pain and complex neurological conditions,” Cassidy added. “My dad had chronic pain from ankylosing spondylitis for over 30 years. I got to see up close how chronic pain can truly impact quality of life and how difficult it can be to get the right diagnosis and treatment. I also experienced how unpredictable chronic pain can be and how it can impact your livelihood. My dad passed away three years ago, and I keep his memory close as we innovate to address patient needs in chronic pain.”

And thus, a legacy endures.

*Anywhere with a Wifi or cellular connection and sufficiently charged patient controller.

References

^1,2 https://pmc.ncbi.nlm.nih.gov/articles/PMC12505153/