Non-Invasive

Med Device Monday: The Monarch external Trigeminal Nerve Stimulation (eTNS) System: The first non-drug treatment for ADHD

Photo from prnewswire.com

Photo from prnewswire.com

A recent press release from the U.S. Food and Drug Administration (FDA) certainly caught our attention! In April, FDA permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The device, known as the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is for prescription use only and intended to be used in patients ages 7 to12 years old who are not currently taking prescription ADHD medication. The device was developed by NeuroSigma, and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.

ADHD is a common disorder that often begins in childhood, with symptoms including inattentiveness, impulsiveness, and very high levels of activity. A diagnosis of ADHD requires a comprehensive evaluation by a health care professional, and for a person to receive an ADHD diagnosis the symptoms must impair the their functioning and cause them to fall behind normal development for his or her age.

The Monarch eTNS System is intended to be used at home under the supervision of a caregiver. The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows. The stimulation should feel like a tingling sensation on the skin, and is administered by the caregiver when the child is asleep. The device is purported to stimulate the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

The FDA reviewed the Monarch eTNS System via the de novo premarket review pathway (previously blogged about HERE and HERE), a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. The main mitigation measures included biocompatibility evaluation, software validation, shelf life testing, electromagnetic compatibility and electrical safety testing. While the Classification Order has been released by FDA, we look forward to posting more info about the details of the testing that NeuroSigma provided in their de novo once the Decision Summary is made public.

Additional Reading:

1.       FDA Press Release

2.       FDA Classification Order

3.       NeuroSigma

4.       About ADHD

5.       ADHD Support Organizations

MDMonday: MiniMed 670G Glucose Monitor and Insulin Pump for Pediatric Populations

Image from http://www.medtronicdiabetes.com/

Image from http://www.medtronicdiabetes.com/

 

In September of 2017, FDA approved a device for patients with type 1 diabetes aged 14 and up. The device, called the MiniMed 670G, is a hybrid, closed-loop system that provides automated insulin delivery with little to no input from the user. The system includes a glucose-measuring sensor that attaches to the body, an insulin pump that straps to the body, and an infusion patch that connects to the pump with a catheter. This catheter is the way through which the insulin is delivered. Very recently, FDA expanded the approval of this device for use in younger pediatric patients, which now include children aged 7 to 13 with type 1 diabetes.

In patients with diabetes, the body’s ability to make or react to insulin is impaired, and doesn’t function correctly. The pancreas makes little or no insulin in people who have type 1 diabetes. This means that they must keep track of their glucose levels throughout the day, and inject insulin at certain points so they can avoid high glucose levels. FDA Commissioner Scott Gottlieb, M.D. recognizes the struggle for patients with type 1 diabetes, and stated, “Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives.” The MiniMed 670G helps to combat hypoglycemic episodes by measuring the glucose levels of the user every five minutes, and automatically adjusting insulin levels by either withholding insulin or administering it. While the device can adjust insulin levels automatically, users must manually request insulin to counter the consumption of carbohydrates at any mealtime.

For this approval, FDA analyzed data from clinical trials of the MiniMed 670G that spanned 105 individuals, aged 7 to 11 years of age. Each participant wore the device for just over three months, and participated in three different phases of the study so both at-home use and remote use could be monitored. At the conclusion of the study, no serious adverse events were found associated with the MiniMed 670G, and it was determined that the device was safe for use in those aged 7 to 13 with type 1 diabetes. FDA Commissioner Scott Gottlieb, M.D. states that, “Advances in science, technology and manufacturing are contributing to the development of new and expanded uses of products that can help improve the quality of life for those with chronic diseases, especially vulnerable populations, like children. Today we’re extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks. The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and to ensuring that the path to market is both efficient and effective.”

Getting treatments to pediatric populations has been an ongoing goal for both FDA and industry. Historically, medical device manufacturers and investors have been wary of expanding their products to children as the risk was seen to be too great. Nobody wants to see injured kids due to a medical technology...it's bad for business and clearly bad for the children, their families, and their healthcare providers. With this in mind, FDA has implemented policies in the past few years (e.g. sections of the 21st Century Cures Act) that helps industry help children. Getting much needed technology scaled to be appropriate for children is critical to help these populations get the treatment they need! We applaud medical device manufacturers who are (safely) working on treating these vulnerable populations.

Further Reading:

  1. FDA and Pediatrics

  2. 21st Century Cures Act: Sections that Impact FDA

  3. Press Announcement about MiniMed670G Approval

Medical Device Monday: Cala ONE's Essential Tremor Device

What happens when experts in the fields of neuroscience, consumer electronics, and data science come together? While your first thought is likely, "the most epic party ever," the correct answer is: they develop a cutting-edge neuromodulation device. Cala ONE, by Cala Health, is a non-invasive, neuroperipheral therapy device that aims to provide transient relief of hand tremors in adults with essential tremor. The device is another success story out of the de novo program at FDA, and was granted marketing authorization this past April (2018). To understand the impact of the device, let’s talk a little more about essential tremors.

Essential tremor (ET), also once known as familial tremor, is a common movement disorder affecting almost 10 million Americans, and millions more worldwide. The condition is often confused with Parkinson’s, and causes rhythmic trembling of the limbs, head, and voice. The constant shaking makes it difficult to perform even the most basic daily activities like eating, drinking, and writing. Although the exact causes and mechanisms of the disorder are unknown, it is believed that they are mostly inherited, and are caused by tremulous activity within a central tremor neural network.

Current treatment options for tremors centralize almost entirely around medications. Some of these medications include beta-blockers and anti-seizure drugs that often have undesirable side effects. In cases where medications fail, alternative treatments like Botox injections or invasive surgical options are used, which can also be just as dangerous as the side effects that come with medication. Cala ONE promises to be a non-invasive, non-pharmacological targeted nerve stimulator for symptomatic relief of hand tremors. The device, which looks quite similar to a fitness tracker or smart watch, delivers patterned electrical stimulation to the median and radial nerves— part of the peripheral nervous system— in the wrist, through the skin.  Two randomized controlled studies, one being an in-clinic study that included 77 participants, and the other an at-home study that included an additional 61 participants, showed marked improvement in those that received treatment stimulation when compared to those that received sham stimulation. Cala ONE is another device in the ever-expanding area of personalized medicine wherein a physician can measure an individual’s tremor using on-board sensors and tailor the treatment according to the patient.

 

Image from mobilehealthnews.com

 

This new device aims to benefit people with ET who might not be able to do things that were once second nature to them. Our abilities to hold someone’s hand, throw a dog a ball, enjoy a home-cooked meal, and write our name are often taken for granted. Thanks to neuroscience, consumer electronics, and data science experts coming together (and likely having an epic party of the minds), this device stands to benefit many people who have been unable to take those actions for granted.

 

Suggested Reading:

  1. FDA de novo Classification Order

  2. Cala Health Website

  3. More information about Essential Tremor