electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Reduce Ileus After Major Colorectal Surgery
The study enrolled forty subjects and was undertaken to explore the safety and feasibility of self-administered non-invasive vagus nerve stimulation (nVNS) to treat ileus after major colorectal surgery. Ileus occurs in 10-20% of patients who have undergone elective colorectal surgery. Ileus is a distressing condition characterized by abdominal distension, persistent vomiting, and delayed faecal elimination after surgery. For patients, it prolongs the length of hospital stays and increases the risk of serious complications such as pneumonia and venous thrombo-embolic events. For healthcare systems, ileus increases per patient costs by up to 71%, particularly those associated with nursing care, laboratory investigations, and medications.1
In pre-clinical models of ileus, electrical stimulation of the vagus nerve has been shown to reduce intestinal inflammation and accelerate the recovery of bowel function. This is thought to be mediated by the cholinergic anti-inflammatory pathway in the gut.2 Historically, vagus nerve stimulation (VNS) required a costly and highly invasive surgical procedure to permanently implant an expensive medical device with attendant risks of neurovascular injury. nVNS mitigates these risks since stimulation can be achieved over the cervical spine region without implantation. The company’s gammaCore therapy uses a handheld device enabled by a proprietary high-frequency burst waveform that safely and comfortably passes through the skin and stimulates therapeutically relevant fibers in the vagus nerve.
The study established the safety, treatment compliance, and usability of self-administered nVNS in patients undergoing major colorectal surgery. Patients were able to self-administer nVNS consistently before and after surgery with infrequent, non-serious, and similar adverse events across both Active and Sham groups, indicating a satisfactory safety profile. While the study was not powered to demonstrate statistically significant improvement in any clinical measure, the group using nVNS showed a greater improvement in several clinically important endpoints, including time to first flatus, tolerance of solid diets and a composite measure of bowel function (GI-3) compared to the Sham group. Benefits were most prominent in subjects who had right-sided surgeries, which may be related to increased manipulation of the duodenum and small bowel in these surgeries. In this population (n=8) there was also a 25.6% decrease in the consumption of oral morphine equivalents in the three days post-surgery between the Active and Sham arms (96 mg vs. 129 mg).
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The full publication is available at: https://onlinelibrary.wiley.com/doi/10.1111/codi.15561
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gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within NHS England.
- Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Patients should not use gammaCore if they:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
In the US, the FDA has not cleared gammaCore for the treatment of ileus. In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.
Please refer to the gammaCore Instructions for Use for all the important warnings and precautions before using or prescribing this product.
The United States FDA has authorized use of the gammaCore Sapphire CV device for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive vagus nerve stimulation (VNS) on either side of the patient’s neck, available under an emergency access mechanism called an EUA.
gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
gammaCore Sapphire CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization.
gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.
Further information is available at:
Authorization Letter: https://www.fda.gov/media/139967/download
Fact Sheet for Healthcare Providers: https://www.fda.gov/media/139968/download
Fact Sheet for Patients: https://www.fda.gov/media/139969/download
Instructions for gammaCore use https://www.fda.gov/media/139970/download
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects, sales and marketing, and product development plans, future cash flow projections, anticipated costs, its pipeline or potential markets for its technologies, the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat ileus, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business, sales and marketing, and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.
1 Mao H. Milne TGE.
2 de Jonge WJ. van der Zanden EP. The FO. Bijlsma MF. van Westerloo DJ. et al. Stimulation of the vagus nerve attenuates macrophage activation by activating the Jak2-STAT3 signaling pathway. Nat Immunol 2005;6:844-851.