Dr. Alan Schwartz et al. evaluate the physiologic mechanisms by which transvenous phrenic nerve stimulation (TPNS) successfully treats Central Sleep Apnea (CSA) in a male patient presenting with CSA and atrial fibrillation
MINNETONKA, Minn. – June 22, 2020 – The Journal of Clinical Sleep Medicine (JCSM) May 2020 issue features the case report of a patient with Central Sleep Apnea (CSA) / Cheyne-Stokes respiration (CSR) who was implanted with a transvenous phrenic nerve stimulation (TPNS) device. The report demonstrates the physiologic pathway by which TPNS successfully treated the CSA/CSR breathing pattern.
We focused on the mechanism for therapeutic responses to transvenous phrenic nerve stimulation,” says Dr. Alan Schwartz, University of Pennsylvania Perelman School of Medicine. “TPNS captures ventilation and successfully extinguishes CSA/CSR without overdriving ventilation or disrupting sleep. This study demonstrates exactly how TPNS stabilizes breathing patterns overnight, restores quality sleep and improves quality of life.
The report demonstrates the mechanism of action of transvenous phrenic nerve stimulation to entrain breathing in patients with central sleep apnea. It provides potential physiological explanations for the improvements in periodic breathing, gas exchange, sleep architecture, and quality of life that were observed in the Pivotal Trial.
“We are grateful for the detailed approach by Dr. Schwartz, Mr. Sgambati, Dr. Samtani, and Dr. Berger to better demonstrate the mechanisms for physiologic responses to the remedē System. We recognize that TPNS, and specifically the remedē System, represents a novel approach to therapy for central sleep apnea, and we look forward to additional publications on both the physiology and patient response.” said Dr. Robin Germany, Chief Medical Officer of Respicardia.
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 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.
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. 36-month safety and efficacy data was published in Sleep in July 2019.
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.
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 +1-312 702 6036 or email email@example.com.
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