Respicardia Announces Highmark Coverage for the remedē® System in Patients with Central Sleep Apnea

The remedē® System The remedē® System

Respicardia, Inc., the manufacturer of the only FDA-approved active implantable system for the treatment of central sleep apnea (CSA), announced today that Highmark Blue Cross Blue Shield and its affiliates will provide coverage for the Company's remedē® System therapy, effective immediately. Highmark provides health insurance coverage to over 5 million individuals across Pennsylvania, Delaware and West Virginia.

"We are pleased by this coverage decision from Highmark as it provides needed member access to this proven therapy option" said Peter Sommerness, CEO of Respicardia. "With published clinical data demonstrating sustained safety and efficacy treating CSA through 36 months, we are encouraged by these updated coverage policies that now include the remedē® System."

Highmark is among the top 10 largest health insurers in the United States and the fourth-largest Blue Cross and Blue Shield-affiliated company. With the addition of the Highmark coverage policy, the remedē® System is now included in commercial insurance coverage policies that represent nearly 28 million covered lives and is also available at VA facilities across the United States.

About Central Sleep Apnea (CSA) and the remedē® 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 remedē 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.

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 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 of the risks and benefits associated with the implantation of the remedē System. Rx only. For further information, please visit www.respicardia.com, call +1-952-540-4470 or email info@respicardia.com.

References
  1. Costanzo M, et al. Transvenous neurostimulation for central sleep apnea: a randomised controlled trial. The Lancet. 2016; 388: 974–82.
  2. Fox H, et al. remedē® 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. doi.org/10.1093/sleep/zsz158.
  3. Costanzo M.R., 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.
  4. Javaheri S., et al. Effects Of Transvenous Phrenic Nerve Stimulation On Central Sleep Apnea And Sleep Architecture: The 5 Year Analysis [abstract]. CHEST. 2020.
  5. FDA PMA P160039 https://www.fda.gov/medical-devices/recently-approved-devices/remeder-system-p160039