Houston’s Michael E. DeBakey VA Medical Center first VA hospital to treat a patient with the remedē® System
Respicardia, Inc. announced today that The Houston Michael E. DeBakey VA Medical Center is the first U.S. Department of Veterans Affairs Hospital (VA) to treat a patient with the remedē® System, an implantable device that uses phrenic nerve stimulation to treat central sleep apnea (CSA). Dr. Hamid Afshar and Dr. Paul Schurmann led the procedure, supported by Dr. Irakli Giorgberidze, Director of Electrophysiology. The remedē® System was approved for inclusion in the Government Services Administration (GSA) Federal Supply Schedule (FSS) in 2018. The Houston VA is also the first medical center to perform a de novo commercial procedure in the state of Texas.
“Many veterans suffer from obstructive sleep apnea, but those with central sleep apnea have very few treatment options. The remedē system is an important option for our veterans in need” says Dr. Sharam Moghtader, a VA sleep medicine physician. A recent study on VA patients, published in the peer-reviewed journal SLEEP, found that veterans with CSA were at an increased risk for hospital admissions related to cardiovascular disorders and highlighted the need for standardized evaluation of CSA in high-risk populations1. “Our electrophysiology team is happy to contribute to this multi-disciplinary program to treat central sleep apnea. We are eager to leverage our experience with implantable devices to help these patients who suffer from CSA,” said Dr. Afshar. “I truly believe that the treatment of CSA contributes to the overall health of these patients, specifically cardiovascular and diabetes management.”
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 patterns2. The remedē System received U.S. Food and Drug Administration (FDA) approval in October 2017 and is commencing market release in a limited number of centers in the United States and Europe.3
“We congratulate the multi-disciplinary team at Michael E. DeBakey VA Medical Center, especially Dr. Afshar, Dr. Schurmann, Dr. Giorgberidze, Dr. Sharafkhaneh, and Dr. Moghtader for their leadership in launching a remedē program,” said Peter Sommerness, President and CEO of Respicardia. “We believe this is the first step in making the therapy available to veterans throughout the country who suffer from CSA.” Additional VA medical centers in Iowa, Milwaukee, Minneapolis, Long Beach, Indianapolis, and Charleston have also signed on to offer the therapy.
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 results from the brain’s inability to send appropriate signals to the respiratory muscles to stimulate breathing. People with CSA often suffer from chronic fatigue, excessive daytime sleepiness, memory and concentration problems, and depression which substantially reduces quality of life. Untreated CSA has also been shown to be associated with higher rates of heart failure and atrial fibrillation.4,5
The remedē System treats the harmful effects of CSA by restoring a more normal breathing pattern during sleep. The remedē System pivotal clinical trial, published in The Lancet, demonstrated that transvenous neurostimulation with the remedē System can significantly reduce the severity of CSA, improve sleep, and improve both quality of life and patient satisfaction. Recently published data in the American Journal of Cardiology (12 month follow-up data) and SLEEP (24 and 36 month follow-up data) demonstrate continued, long term efficacy of the therapy.2,6,7
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 call +1-952-540-4470 or email firstname.lastname@example.org.
1 Ratz D, Wiitala W, Badr MS, et al. Correlates and consequences of central sleep apnea in a national sample of US veterans. The Lancet. 2016; 388: 974–82
2 Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. SLEEP. 2018; doi: 10.1093/sleep/zsy058
3 FDA PMA P160039 https://www.fda.gov/medical-devices/recently-approved-devices/remeder-system-p160039
4 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
5 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.
6 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.
7 Fox H, Oldenburg O, Javaheri S, 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.