finanzen.net
20.04.2019 00:12
Bewerten
(0)

FDA permits marketing of first medical device for treatment of ADHD

DRUCKEN

SILVER SPRING, Md., April 19, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

"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."

ADHD is a common disorder that begins in childhood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. The diagnosis of ADHD requires a comprehensive evaluation by a health care professional. For a person to receive a diagnosis of ADHD, the symptoms of inattention and/or hyperactivity-impulsivity must be chronic or long-lasting, impair the person's functioning and cause the person to fall behind normal development for his or her age.

The Monarch eTNS System is intended to be used in the 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, and should feel like a tingling sensation on the skin. The system delivers the low-level electrical stimulation to 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.

The stimulation should feel like a tingling sensation on the skin, and the device should be used in the home under the supervision of a caregiver during periods of sleep. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident. Patients should consult with their health care professional after four weeks of use to assess treatment effects.

The Monarch eTNS System's efficacy in treating ADHD was shown in a clinical trial that compared eTNS as the sole treatment, or monotherapy, to a placebo device. A total of 62 children with moderate to severe ADHD were enrolled in the trial and used either the eTNS therapy each night or a placebo device at home for four weeks. The trial's primary endpoint was improvement on a clinician-administered ADHD Rating Scale, ADHD-RS.  ADHD-RS scales are used to monitor severity and frequency of ADHD symptoms. A higher score is indicative of worsening symptoms. The ADHD-RS uses questions about the patient's behavior, such as whether they have difficulty paying attention or regularly interrupt others. The trial showed that subjects using the eTNS device had statistically significant improvement in their ADHD symptoms compared with the placebo group. At the end of week four, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.

The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.

The Monarch eTNS System should not be used in children under seven years of age. It should not be used in patients with an active implantable pacemaker or with active implantable neurostimulators. Patients with body-worn devices such as insulin pumps should not use this device. The eTNS System should not be used in the presence of radio frequency energy such as magnetic resonance imaging (MRI), because it has not been tested in an MRI machine, or cell phones, because the phone's low levels of electromagnetic energy may interrupt the therapy.

The FDA reviewed the Monarch eTNS System through the de novo premarket review pathway, 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 FDA granted marketing authorization of the Monarch eTNS System to NeuroSigma. 

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For more information:

  • FDA: Medical devices
  • FDA: De novo pathway
  • NIH: Attention Deficit Hyperactivity Disorder

Media Inquiries: Stephanie Caccomo, 301-348-1956, stephanie.caccomo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-permits-marketing-of-first-medical-device-for-treatment-of-adhd-300835320.html

SOURCE U.S. Food and Drug Administration

Anzeige
Anzeige
Börse Stuttgart Anlegerclub

Die richtige Strategie für die Börsenkrise

Stecken Sie nicht den Sand in den Kopf, sondern kaufen Sie die richtigen Aktien. Erfahren Sie im aktuellen Anlegermagazin mehr über attraktive Qualitätsaktien und zyklische Aktien
Kostenfrei registrieren und lesen!

Heute im Fokus

DAX geht über 12.000 Punkten ins Wochenende -- US-Börsen schließen im Plus -- May kündigt Rücktritt an -- VW stellt sich auf Mammutverfahren ein -- adidas, OSRAM, Vapiano im Fokus

Boeing muss 737 Max auf Werksgeländen parken. Trump-Familie geht im Streit um Bankunterlagen in Berufung. Deutsche Börse-Aktie nach Investorentag an DAX-Spitze. Auch Siemens prüft Geschäftsbeziehungen zu Huawei. SMA Solar-Aktie mit Kurssprung. Facebook entfernt mehr als drei Milliarden Fake-Konten.

Die 5 beliebtesten Top-Rankings

Das hat sich geändert
Diese Aktien hat George Soros im Depot
Big-Mac-Index
In welchen Ländern kostet der Big Mac wie viel?
Das verdienen Aufsichtsratschefs in DAX-Konzernen
Deutlich unter Vorstandsgehältern
Apps & Social Media: Die wertvollsten Marken der Welt
Welche Marke macht das Rennen?
Die Länder mit den größten Goldreserven 2019
Wer lagert das meiste Gold?
mehr Top Rankings

Umfrage

Die rechtspopulistische FPÖ in Österreich hat für einen Skandal gesorgt. Wie glauben Sie wird sich das auf die Europawahlen auswirken?

Online Brokerage über finanzen.net

finanzen.net Brokerage
Handeln Sie für nur 5 Euro Orderprovision* pro Trade aus der Informationswelt von finanzen.net!

ETF-Sparplan

Oskar ist der einfache und intelligente ETF-Sparplan. Er übernimmt die ETF-Auswahl, ist steuersmart, transparent und kostengünstig.
Zur klassischen Ansicht wechseln
Kontakt - Impressum - Werben - Pressemehr anzeigen
Top News
Baufinanzierung
14:00 Uhr
100.000 Anträge auf Baukindergeld
Beliebte Suchen
DAX 30
Öl
Euro US-Dollar
Bitcoin
Goldpreis
Meistgesucht
Deutsche Bank AG514000
CommerzbankCBK100
Wirecard AG747206
Daimler AG710000
Scout24 AGA12DM8
Apple Inc.865985
TeslaA1CX3T
Amazon906866
Huawei TechnologiesHWEI11
Allianz840400
BMW AG519000
BASFBASF11
NEL ASAA0B733
BayerBAY001
E.ON SEENAG99