Mountain Vista Medical Center, a Steward family hospital, today announced they are the first hospital in Arizona to implant the remedē® 1100 device, a breakthrough treatment device for adult patients with moderate to severe Central Sleep Apnea (CSA). Individuals with moderate to severe CSA often suffer from chronic fatigue, daytime sleepiness and memory or concentration problems. The device was implanted by Himanshu Shukla, M.D., FAAC, a cardiologist with Mountain Vista Medical Center and founder of the Cardiac Arrhythmia Institute (CAI).

“The device provides innovative therapy for patients with CSA,” said Dr. Shukla. “This therapy has been proven to reduce the number of sleep apnea events, which improves daytime sleepiness and quality of life.”

Central sleep apnea is a serious type of sleep-disordered breathing that occurs when the brain does not send the correct signals to the breathing muscles (the diaphragm). The result is an inconsistent breathing rhythm and pattern, leading to repeated arousals from sleep, drops in oxygen levels in the blood, and increased cardiac stress response. For the approximately 75 percent of CSA patients that have heart failure and/or atrial fibrillation, these central apnea events substantially compound the negative impact of their cardiovascular disease, contributing to the downward cycle of heart failure and leading to higher mortality and hospitalizations.2,3

The FDA-approved remedē® System is an implantable therapy that monitors and stabilizes the breathing pattern to restore sleep throughout the night. The remedē® System is placed by a cardiologist during a minimally invasive outpatient procedure. When the patient is asleep, the remedē® System stimulates the phrenic nerve in a patient’s chest, sending signals to the diaphragm that stimulate breathing in the same way that the brain signals breathing.

In a clinical study, the remedē  System has been shown to significantly reduce the effects of CSA:

• 89 percent of patients had a reduction in the number of sleep apnea events4
• 78 percent patients had an improvement in quality of life4
• 95 percent patients reported they would “elect to have the medical procedure again”4
• Patients treated with remedē® System also demonstrated clinically significant reduction in daytime sleepiness4,5

The symptoms of CSA can be subtle and often overlap with symptoms from other causes such as chronic heart failure, atrial fibrillation, and stroke. To diagnose CSA, a physician will prescribe a home or in-lab sleep study to determine whether the sleep disturbance results from inappropriate signals from the brain (CSA) or an airway blockage (obstructive sleep apnea, or OSA).

For more information about Mountain Vista Medical Center and its services, please visit mvmedicalcenter.org.            

About Mountain Vista Medical Center

Mountain Vista Medical Center is a 178-bed, state-of-the-art hospital located in east Mesa, Arizona, offering comprehensive health care services, including emergency care, heart care, advanced surgical procedures, orthopedics, breast care, maternity care, women’s services, and help for a broad range of medical conditions. The Medical Center is equipped with the most advanced medical technology, in a resort-like setting, with features that include all private rooms, electronic health records, room service, and wireless Internet access.

About Steward Health Care System

Nearly a decade ago, Steward Health Care System emerged as a different kind of health care company designed to usher in a new era of wellness. One that provides our patients better, more proactive care at a sustainable cost, our providers unrivaled coordination of care, and our communities greater prosperity and stability.

As the country’s largest physician-led, tax paying, integrated health care system, our doctors can be certain that we share their interests and those of their patients. Together we are on a mission to revolutionize the way health care is delivered - creating healthier lives, thriving communities and a better world.

Steward is among the nation’s largest and most successful accountable care organizations (ACO), with more than 5,500 providers and 43,000 health care professionals who care for 12.3 million patients a year through a closely integrated network of hospitals, multispecialty medical groups, urgent care centers, skilled nursing facilities and behavioral health centers. 

Based in Dallas, Steward currently operates 39 hospitals across Arizona, Arkansas, Florida, Louisiana, Massachusetts, Ohio, Pennsylvania, Texas and Utah.

REFERENCES

Abraham, et al. Cardiac Failure Review 2018;4(1):50–3. DOI: https://doi.org/10.15420/cfr.2018:9:1

Khayat et al.  2015;36:1463-9  Eur Heart J

Khayat et al.  J Card Fail 2012;1 8:534-540

Costanzo, M. R., Ponikowski, P., Javaheri, S., et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. The American Journal of Cardiology. 2018; DOI:10.1016/j.amjcard.2018.02.022.

Costanzo M, et al. Transvenous neurostimulation for central sleep apnea: a randomized controlled trial. The Lancet. 2016; 388: 974-82.

The remedē® System

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 remede.zoll.com, call +1-952-540-4470 or email [email protected].

The remedē® System, remedē® EL System, and remedē® EL-X System have received FDA approval. The remedē® System model 1001 has received CE Mark approval.

Copyright © 2021 ZOLL Medical Corporation. All rights reserved. Respicardia and remedē are registered trademarks of ZOLL Respicardia, Inc. in the United States and/or other countries. ZOLL is a registered trademark of ZOLL Medical Corporation in the United States and/or other countries.

MKT1624, Rev B