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

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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

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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'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

Med Device Monday: Safer C-sections

Many medical conditions and complications can be and are diagnosed ahead of time, resulting in planned cesarean sections. Of course, emergencies still happen, and in fact, the National Institutes of Health reports that there has been a rise in the numbers of both elective/planned c-sections, and second stage c-sections in the past 20 years.  

The second stage of labor is the point in delivery when the cervix is fully dilated, and the baby is making its way through the vagina and out into the world. While only 1-3% of c-sections occur at this point in the process, they are, as you might imagine, more dangerous and potentially traumatic for mother and child. When the baby's head may already be in the birth canal and doctors have to reach farther into the body, risks are higher and include tears or damage to the cervix, vagina, and uterus, hemorrhage, and extended hospital stays. 

In fact, some reports are that up to 57% of mothers who have a second stage c-section experience some of these complications. 

Fetal pillow is a new medical device from Safe Obstetrics, and it aims to reduce these complications by getting the baby's head out of the birth canal prior to a second stage c-section.

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Fetal pillow consists of a small inflatable device that is inserted into the vagina, and then moved down below the baby's head, between it and the coccyx to prevent injury. An attached tube is used to fill the "pillow" with saline and push the baby's head out of the birth canal and back into the uterus. 

When used correctly, this simple, Class II prophylactic device can result in safer, easier births with better patient outcomes for both mother and baby. It reduces complications and length of hospital stays, cuts down on blood loss, and reduces chance of injury to mother and child. 

I love seeing devices like this come into the marketplace! A true win for all in the form of a beautifully simple and effective solution.


Further reading:

Fetal pillow device classification

You can see actual footage (warning: this is not a cartoon) of the fetal pillow being used during a live c-section

Med Device Monday: Easier Umbilical Venous Catheterization

A month or so ago, we talked about the first MRI device created specifically for neonates. This week, we're talking about a special catheterization device to make certain IV procedures on neonates safer and easier. As a reminder, August on this here blog is dedicated to discussing up and coming medical devices that have not yet gained FDA approval. 

The umbilical vein is unobstructed and available in newborns for about the first week of their life. It is generally the easiest way to start a catheter/IV in a very young baby, especially in an emergency, and many lifesaving neonatal procedures rely on this vein for access. Per Navitechnologies, "Roughly 30% of patients admitted to Neonatal Intensive Care Units (NICUs) require a potentially life-saving procedure called an Umbilical Venous Catheterisation (UVC). UVC procedures provide a vital pathway to deliver nutrients and drugs to critically-ill babies."

Unfortunately, the vein can be difficult to locate, and mistakes can be harmful - or even fatal. 

In fact, Navitechnologies says, "Current techniques are inadequate where 40% of attempts result in misplaced catheters due to lack of real-time feedback."

If you guessed that Navitechnologies is talking about this because they have a medical device for it, you would be correct!

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Navitechnologies' device, NeoNAV, is designed to make placement of a UVC accurate and safe the first time. Using technology, it provides realtime feedback as to the placement of the end of the catheter, guiding the clinician and ensuring the catheter is following the vein. It's not a new catheter system, but rather an add-on for existing ones. 

Since this is a fairly new device that has not yet been approved, there are no videos or pictures of the interface, but I love the idea of technology improving an existing medical device to make it easier, safer, and more effective. Their website says that a "traffic-light system" guides the clinician thanks to their proprietary algorithm. Proprietary algorithms for the win!

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Neonatal care has certainly come a long way. It wasn't terribly long ago that premature babies and certain, now-survivable medical conditions meant death for a newborn (and often, its mother). While we have of course made awesome progress, it is so exciting to me to see these new devices that are specifically designed for the specialized care of newborns. I can't wait to see what comes out next!


Further reading:

FDA's page for pediatric devices

Incubator product classification (throwing it old school, because it's still essential!)

First neonatal MRI device

Med Device Monday: Artificial Womb

Here at Med Device Monday, we explore a variety of topics. From specific medical devices to the role of technology to what FDA has been up to. Today we're talking about a device that's not yet on the market, but which certainly makes it seem like the future is now!

It wasn't that long ago that it was common for women and babies to die in childbirth. As American medicine advanced and healthcare improved along with our understanding of safe labor and delivery, women survived more and babies did too. As time has marched on, fetal viability has increased, while time necessary in the womb has decreased: fetuses can now sometimes survive after just 22 weeks in utero. It appears that time may only continue to shorten as we see the introduction of artificial wombs. 

Before we go further, let's be clear: the best place for a developing fetus is inside a healthy and willing mother. The ideal is for babies to stay inside and develop in their natural environment for as long as they need to, because the earlier a baby is born, the higher the risk for complications, lifelong medical problems, and death. But as we know, remaining in utero is not always possible. And if babies are or need to be born prematurely, technology and medicine continue to advance to save them

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An article from NPR discusses the artificial womb seen above. While this technology is not yet ready for human fetuses, it has been successful in keeping lamb fetuses alive for about a month. As soon as babies take their first breath of air, their lungs cease developing, which has all kinds of long-ranging implications. The study explains the intent of the device quite nicely:

"In the United States, extreme prematurity is the leading cause of infant morbidity and mortality, with over one-third of all infant deaths and one-half of cerebral palsy attributed to prematurity. Advances in neonatal intensive care have improved survival and pushed the limits of viability to 22 to 23 weeks of gestation. However, survival has been achieved with high associated rates of chronic lung disease and other complications of organ immaturity, particularly in infants born before 28 weeks. In fact, with earlier limits of viability, there are actually more total patients with severe complications of prematurity than there were a decade ago. Respiratory failure represents the most common and challenging problem, as gas exchange in critically preterm neonates is impaired by structural and functional immaturity of the lungs. This condition, known as bronchopulmonary dysplasia, is now understood to be related to an arrest in lung development secondary to premature transition from liquid to gas ventilation, explaining why even minimally invasive modes of neonatal ventilation have not reduced the incidence of bronchopulmonary dysplasia. There is clearly an urgent need for a more physiologic approach to support the extreme premature infant."

The "womb" is a clear plastic bag in which the fetus is placed, along with artificial amniotic fluid. Outside of the bag, a machine attached to the umbilical cord functions as a placenta, a concept the study says has been the subject of research for 50 years. The "placenta" functions as an organic one does, furnishing nutrition and oxygen and taking away carbon dioxide. The fetus is monitored with ultra sounds, and it even gets to hear soothing recordings of a mother's heartbeat.

One thing that I think is extra cool about this device is that it may not only save lives, but will likely provide further insight into fetal development. Check out this little lamb in its artificial environment. It's truly something to behold.

As previously stated, actual approval and usage of a device like this for humans is a long way off. Not only are there obvious medical risks, but there's an ethical discussion to be had, too. The leaders of the study say they have no intentions of using a device like this to increase viability outside of the womb: they say they wouldn't use it on fetuses before 22 weeks. But of course, just the possibility of a device like this does open the door.  There are many factors worth considering for a potential device like this, but from a medical standpoint, it is pretty impressive. 


Further reading:

Study of artificial womb on lamb fetuses

NPR article