Transvenous Phrenic Nerve Stimulation (The remedē System) Shows Sustained Safety and Efficacy Through 5 Years

The remedē® System. The remedē® System.

Trial results showed consistent improvement in sleep disordered breathing, arousals, sleep architecture, and daytime sleepiness through 5 years.

Respicardia has announced 5-year results from the remedē System Post Approval Study, assessing the safety and efficacy of transvenous phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea (CSA). The data was presented at late-breaking sessions at two international scientific conferences, Heart Failure Society of America (HFSA) 2020 and CHEST 2020. 

The remedē System was approved to treat moderate to severe CSA in adult patients by the U.S. Food and Drug Administration (FDA) in 2017.1 The remedē System is an implantable device that activates automatically each night to stimulate a nerve in the chest (phrenic nerve) that sends signals to the breathing muscles (diaphragm) to help restore a normal breathing pattern.2 The Post Approval Study followed patients from the pivotal trial through 5 years post implant.

"Since the initial trials, transvenous phrenic nerve stimulation has proven to be effective and safe in treating moderate to severe central sleep apnea. Demonstrating sustained benefit through five years is very significant for patients with this disease. The sustained benefit of the therapy is critically important for heart failure patients, whose disease is chronic and progressive," said Dr. Maria Rosa Costanzo, Principal Investigator for the Pivotal Trial of the remedē System and Medical Director at Edward Hospital Center for Advanced Heart Failure and Heart Failure Research at Advocate Heart Institute. "We also saw substantial and clinically meaningful improvements in the sleep architecture. The shift to more deep stage sleep seen in this study may partially explain the positive impact this therapy has shown on arousal reduction and overall quality of life improvement. It is important that clinicians who see patients with central sleep apnea consider this therapy."

Highlights from the 5-year data show sustained improvements from baseline that were highly consistent with the previously published 6-, 12-, 24-, and 36-month results.3 The 5-year results include:4,5

  • 96% reduction in central apneas
  • Overall apnea hypopnea index (AHI) reduced by 22 events/hour of sleep
  • Arousals reduced by 14 events/hour of sleep
  • Fourteen percentage point (absolute) increase in deep sleep (N2 – REM) and a 19 percentage point decrease in light stage sleep (N1)
  • Sustained improvement in daytime sleepiness
  • Consistent safety, in line with previously published data.

"Congratulations to all of the coauthors, study investigators, and patients who have contributed to the data collection and publication of this 5-year study." said Dr. Robin Germany, Chief Medical Officer of Respicardia. "This is an important milestone showing durable, long-term effectiveness and a strong safety profile. We will continue to advance research on central sleep apnea and transvenous phrenic nerve stimulation as we increase access to the therapy for patients in need."

About Central Sleep Apnea (CSA)
Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects sleep quality, quality of life, and is associated with poor outcomes. CSA results from the brain's inability to send appropriate signals to the respiratory muscles to stimulate breathing.

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

Important Safety Information

The remedē 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 remedē System is right for you. You will not be able to have an MRI or diathermy (special heat therapies) if you have the remedē System implanted. The remedē 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 remedē 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 the risks and benefits associated with the implantation of the remedē System. Rx only. For further information, please visit www.respicardia.com, call +1-312 702 6036 or email info@respicardia.com.

References

1 FDA PMA P160039 https://www.fda.gov/medical-devices/recently-approved-devices/remeder-system-p160039              

2 Costanzo MR, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. Lancet. 2016;388:974-982.

3 Fox H, Oldenburg O, Javaheri S, et al. Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea. Sleep. https://doi.org/10.1093/sleep/zsz158

4 Costanzo MR, Ponikowski P, Oldenburg O. et al. Transvenous Phrenic Nerve Stimulation In Patients With Central Sleep Apnea: 5-Year Safety And Efficacy Results. Poster presented at: Annual Scientific Meeting of the Heart Failure Society of America; October 3, 2020; Virtual.

5 Javaheri S, et al. Effects Of Transvenous Phrenic Nerve Stimulation On Central Sleep Apnea And Sleep Architecture: The 5 Year Analysis [abstract]. Chest. 2020.