10.07.2019 14:05

Treatment Benefits of the remede System Sustained Through 36 Months in Patients with Central Sleep Apnea


MINNETONKA, Minn., July 10, 2019 /PRNewswire/ -- Respicardia, Inc., the manufacturer of the only FDA-approved active implantable device for the treatment of central sleep apnea (CSA), today announced the publication of the 24- and 36-month data from the remede® System Pivotal Trial in the peer-reviewed journal SLEEP. The results demonstrate long-term safety and sustained improvement in sleep metrics from phrenic nerve stimulation in adult patients with moderate to severe CSA through 36 months of remede System therapy.1

Respicardia logo. (PRNewsfoto/Respicardia, Inc.)

"It is imperative that we understand the long-term results of phrenic nerve stimulation since CSA and its underlying disorders are chronic and progressive," said Henrik Fox, MD, Senior Cardiologist at Ruhr-Universität Bochum, Bad Oeynhausen, Germany. "The durability of the clinical results seen in this trial further validates the remede System as an effective, reliable, long-term treatment option for indicated patients."

Patients from the remede System Pivotal Trial were assessed at 24 months (full overnight, in-lab, attended polysomnogram) and 36 months (home sleep study of cardiorespiratory polygraphy) to evaluate sleep metrics and safety. All sleep studies were scored by a central sleep core laboratory. The results at 24-months include:

  • 99% reduction in the median of the central apnea index (CAI) from baseline
  • 93% of patients had a reduction in the apnea-hypopnea index (AHI) from baseline
  • 59% reduction in the median arousal index from baseline
  • Improved rapid eye movement (REM) sleep and the percentage and minutes of sleep with oxygen saturation less than 90%, which is an independent predictor of all-cause mortality in chronic heart failure2
  • 90% of patients were free from serious adverse events associated with the implant procedure, the remede System or delivered therapy through 24 months. No additional related serious adverse events were reported between 24 and 36 months.

The control arm showed similar results once therapy was activated after a pre-specified 6-month randomization period. The improvement in sleep metrics for both groups was sustained and consistent at 36 months.

The latest results build upon prior published data in The Lancet and the American Journal of Cardiology which demonstrated that the remede System significantly reduces the severity of CSA and improves sleep, quality of life and patient satisfaction,3 and the benefits are sustained.4

Along with the publication of this 3-year data, Respicardia also announced the initiation and first patient enrollments into a major new clinical study: the remede System Therapy Study (reST Study), a multi-center, prospective, open-label, single-arm study to collect safety and effectiveness data in approximately 500 remede System patients in the United States and Europe for up to 5 years. To assess effectiveness, the study will evaluate changes in sleep metrics, daytime sleepiness, quality of life and, for patients with heart failure, core-lab determined cardiac remodeling biomarkers as well as functional capacity. The first global enrollments occurred July 9, 2019 at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina and were implanted by Dr. Michael N. Drucker who commented, "We are very excited to be leading the way and enrolling the first two patients into the reST Study. Phrenic Nerve Stimulation has enormous potential to treat central sleep apnea patients who currently have few therapeutic options. The reST Study will give us further insight into the impact of the therapy and long-term outcomes."

"We are dedicated to offering physicians and their patients a clinically proven CSA treatment option with long-term safety and benefits," said Peter Sommerness, President and CEO of Respicardia. "The 3-year data from the IDE Pivotal Trial combined with the initiation of the reST Study further strengthens our clinical foundation and supports our commitment to improving patient outcomes."

About Central Sleep Apnea (CSA) and the remede® System
Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health. CSA results from the brain's inability to send appropriate signals to the respiratory muscles to stimulate breathing.

The remede System, which received U.S. Food and Drug Administration (FDA) approval in October 2017, is a breakthrough implantable system that treats the harmful effects of CSA by restoring a more normal breathing pattern during sleep.

CMS granted the remede System the New Technology Add-on Payment5 (NTAP) in August 2018 and the Transitional Pass-through Payment6 (TPT) in November 2018. The remede system is the only technology to receive the TPT since 2015. These programs recognize innovative medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries.

About Respicardia
Respicardia is a leader in innovative technologies that address the unmet needs in respiratory and cardiovascular disease with safe and effective therapies. Founded in 2006 and headquartered near Minneapolis, Minn., Respicardia is dedicated to improving patient outcomes, quality of life and overall cardiovascular health via novel transvenous neurostimulation therapies. Learn more at

Important Safety Information
The remede System is indicated for moderate to severe Central Sleep Apnea in adult patients.

Your doctor will need to evaluate your condition to determine if the remede System is right for you. You will not be able to have an MRI or diathermy (special heat therapies) if you have the remede System implanted. The remede System may be used if you have another stimulation device such as a heart pacemaker or defibrillator; special testing will be needed to ensure the devices are not interacting.

As with any surgically implanted device, there are risks related to the surgical procedure itself which may include, but are not limited to, pain, swelling, and infection.

Once the therapy is turned on, some patients may experience discomfort from stimulation and/or from the presence of the device. The majority of these events are resolved either on their own or by adjusting the therapy settings. The remede System may not work for everyone. There are additional risks associated with removing your system. If you and your doctor decide to remove the system, another surgery will be required.

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the remede System. Rx only. For further information, please visit, call +1-952-540-4470 or email


  • Fox H, et al. remede® System Pivotal Trial Study Group, Long-term Efficacy and Safety of Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea Outcomes of Phrenic Nerve Stimulation for Central Sleep Apnea, Sleep.
  • Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, et al. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016;37(21):1695-703.
  • Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82.
  • Costanzo M, et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol. 2018. pii: S0002-9149(18)30258-3. doi: 10.1016/j.amjcard.2018.02.022.
  • CMS-1694-F.  FY2019 IPPS Final Rule.  Vol. 83, No. 160 Pg. 41320.
  • CMS-1695-FC.  CY2019 OPPS Final Rule.  Vol. 83, No. 225 Pg. 58939.

    Cision View original content to download multimedia:

    SOURCE Respicardia, Inc.

    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 beendet Tag im Plus -- Dow trotz Rekord kaum bewegt -- Brenntag meldet Gewinnwarnung -- GERRY WEBER-Aktie im Sinkflug -- Bayer-Strafe deutlich gesenkt -- JPMorgan, Goldman Sachs, CRH im Fokus

    Bitcoin im Sog von Libra-Diskussion. Europaparlament wählt von der Leyen zur EU-Kommissionspräsidentin. Wells Fargo steigert Gewinn. J&J kann Gewinn kräftig steigern und hebt Umsatzausblick an. US-Notenbankchef stellt erneut Leitzinssenkung in Aussicht. ams gibt OSRAM-Übernahmepläne auf. Villeroy & Boch mit Gewinnwarnung.

    Die 5 beliebtesten Top-Rankings

    Diese Sternchen haben ihren eigenen Aktien-Index
    Diese Aktien hat Warren Buffett im Depot
    Die Änderungen unter den Top-Positionen
    Die erfolgreichsten Kinofilme der letzten 25 Jahre
    Welche Titel knackten die Milliardenmarke an den Kinokassen?
    Das verdienen Aufsichtsratschefs in DAX-Konzernen
    Deutlich unter Vorstandsgehältern
    Apps & Social Media: Die wertvollsten Marken der Welt
    Welche Marke macht das Rennen?
    mehr Top Rankings


    Wo sehen Sie den DAX Ende 2019?

    Online Brokerage über Brokerage
    Handeln Sie für nur 5 Euro Orderprovision* pro Trade aus der Informationswelt von!


    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
    Aktie im Fokus
    23:41 Uhr
    Villeroy & Boch mit Gewinnwarnung
    Beliebte Suchen
    DAX 30
    Euro US-Dollar
    Wirecard AG747206
    Deutsche Bank AG514000
    Daimler AG710000
    NEL ASAA0B733
    Microsoft Corp.870747
    Infineon AG623100
    Apple Inc.865985
    Airbus SE (ex EADS)938914
    Deutsche Telekom AG555750
    EVOTEC SE566480