Medical Devices - Health Care Chief

Theranica’s Nerivio Gains FDA 510(k) Nod For Migraine Prevention Device, Theranica Bio-Electronics' wearable gadget for alleviating migraine symptoms, approved by the FDA in 2019, might soon adopt a more aggressive strategy regarding that treatment. The FDA approved the company's request for wider use of the technology only a few months after it had filed a revised 510(k) petition with the agency. Theranica revealed this week that the Nerivio neuromodulation band, available exclusively with a doctor's prescription, may now be used to prevent migraines in addition to curing their symptoms. Those experiencing migraines (with or without aura) and who are aged minimum 12 years old now have the authorization to use the device for prevention. Acute therapy with Nerivio was first approved for use exclusively in adults, but its label was eventually expanded to include the same age bracket roughly two years later. The Nerivio gadget consists of an armband that the user wraps over their upper arm and a mobile application that controls the device's on/off status and intensity level. During each session, electrical pulses are sent from electrodes in the band to the patient's nerve fibers. These pulses aren't harmful to the wearer in any way, but they're supposed to activate the body's natural pain-control systems, which will then distribute calming sensations up the user's nerve system and into their brain. This method has been shown to be effective as an acute therapy for migraine, and new research from last year demonstrated that preventing migraines from ever manifesting by promoting pain relief across the neural system prior to their onset is also feasible. About 250 participants with either chronic or episodic migraines were included in the research. Following eight weeks of therapy, individuals given the Nerivio band reported a four-day monthly reduction in migraine days, whereas those given a placebo reported a decrease of just 1.3 days. On average, the gadget helped people with chronic migraines cut back on their headaches by 4.7 days per month, as compared to 3.2 days for those with episodic migraines. Theranica suggests 45-minute sessions on alternate days for preventative purposes, although patients have complete autonomy over their schedules. CEO Alon Ironi stated in an interview last year following the announcement of the research results and the new FDA application that permitting the Nerivio technology to be utilized in both preventative and severe treatment would render it a far more essential and effective therapy. Theranica has increased the neurostimulation capability of the gadget now that it has dual-use approval; each Nerivio unit may be used for 18 therapy sessions instead of the prior limit of 12. Units are priced at $599, but the firm claims that with insurance and its savings scheme, customers can spend as little as $10 for the initial unit and $49 for refills. Statement front the CEO: “That means, first of all, less dependency on pharmacological agents. It also means less burden, because if you only have one therapy that you have to adhere to, it’s fewer things to worry about,” Ironi remarked. “If you manage to get both significant reductions in your migraine episodes as well as to abort whatever episodes you do experience with the same therapy, that makes your life easier.” Also Read: Death toll linked to Phillips’ respiratory device recall reaches 364

Medical Devices

Theranica’s Nerivio Gains FDA 510(k) Nod For Migraine Prevention Device

Editorial Team

March 3, 2023
3 min read

The death toll linked to Phillips’ respiratory device recall reached 364 back in April 2021, Philips first began publicizing its issues with its bilevel positive airway pressure machines (BiPAP ) and continuous positive airway pressure machines (CPAP) when concerns were raised over the degrading foam in its DreamStation CPAP machines. Before that point, Philips had only sent 30 medical device reports (MDRs) to the FDA regarding the breakdown of PE-PUR foam in the last decade, now however, there are approximately 99,000 MDRs filed against the devices. Just over the past year, 21,000 MDRs have been filed against the recalled devices with complaints peaking from May to July 2022. Since then, although the rate of complaints has reduced, there has been a rise in the death toll. Datasets produced by the Food and Drug Administration (FDA) have listed 123 deaths overall in the first year of the recall; between the months of May to July of that year, the agency listed 45 deaths. The figure for August to October was initially out at 91 but has now gone up to 96 after the company’s review of the MDRs. These are the figures that have been reached after consulting Philips's review of the reports. Since the recall began in the summer of 2021, the rate of deaths per month has only risen each month and as of now, a total of 364 deaths reports have been received. In the final two months of last year alone, 82 deaths have been linked to Phillips’ respiratory device recall. These deaths were reported among the over 800 MDRs that the FDA received between November and December. The most recent figure is yet to be adjusted in light of the firm’s own review, but it is expected that it will be the highest death rate in the dataset. The number of deaths per month has been on the rise. For the last 3 reporting periods, figures rose from 15 to 41. Both Phillips and the FDA, however, have clarified that all the MDRs cannot be linked to the recall. Phillips, in fact, shared the results of its safety tests from last December that covered the majority of the recalled devices and it revealed that the disintegrating foam in the tested recalled devices was unlikely to have been the cause of harm for any patient. The volatile organic compounds released from the foam were not identified as an active threat to patients’ health. “The vast majority (93%) of the approximately 99,000 MDRs filed since April 2021 up to and including December 2022 are alleged technical malfunctions that do not involve serious injury,” Philips said. “Philips Respironics investigates all allegations of technical malfunction serious injury or death. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in certain of these MDRs.” Despite the fact that companies are still rolling out, Philips has continued to work on its repair-and-replace program for its 5.5 million recalled respiratory devices. In a recent update, the company shared that the production required for the delivery of the replacement device was almost 90% done and that the remediation program will likely finish within this year. To read more about this topic, click here.

Medical Devices

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