MINNETONKA, Minn. – November 13, 2020 – Respicardia, Inc. announced today that Novant Health Forsyth Medical Center in Winston-Salem, NC has treated its 25th patient with the remedē® System, an implantable device that treats central sleep apnea (CSA) by using phrenic nerve stimulation. The implant procedure was led by Dr. Michael N. Drucker, electrophysiologist at Novant Health Forsyth Medical Center.
“Since 2014, we’ve used the remedē® System to help patients sleep better and safer,” said Dr. Drucker. “We’re proud to offer innovative treatments to patients across the region and to serve as a resource to our colleagues around the country.”
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.3,4
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 control breathing. It monitors respiratory signals and helps restore normal breathing patterns.1 The remedē System was approved for moderate to severe CSA in adult patients by the U.S. Food and Drug Administration (FDA) in 2017.2
“We are grateful to Dr. Drucker and the entire team at Novant Health Forsyth Medical Center for their commitment to treating patients who suffer from central sleep apnea. Dr. Drucker and his team have played a major leadership role in making this therapy available not only to regional patients, but also a growing number of patients across the Southeast who have struggled with their available treatment options and sought out their expertise,” said Peter Sommerness, President and CEO of 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, Minn. Respicardia is dedicated to improving patient outcomes, quality of life and overall health via novel transvenous neurostimulation therapies. Learn more at www.respicardia.com.
1 Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82
2 FDA PMA P160039 https://www.fda.gov/medical-devices/recently-approved-devices/remeder-system-p160039
3 May A.M., Blackwell T., Stone P.H., et al., for the MrOS Sleep (Outcomes of Sleep Disorders in Older Men) Study Group (2016) Central sleep-disordered breathing predicts incident atrial fibrillation in older men. Am J Respir Crit Care Med 193:783–791
4 Javaheri S., Blackwell T., Ancoli-Israel S., et al., for the Osteoporotic Fractures in Men Study Research Group (2016) Sleep-disordered breathing and incident heart failure in older men. Am J Respir Crit Care Med 193:561–568.
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 firstname.lastname@example.org.
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