ZOLL Announces Approval of Next-Generation remedē System for the Treatment of Central Sleep Apnea (transvenous phrenic nerve stimulation)
The new remedē EL-X model delivers extended longevity, reduced size, and an enhanced suite of diagnostics
The new remedē EL-X model delivers extended longevity, reduced size, and an enhanced suite of diagnostics
ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the peer-reviewed journal Nature and Science of Sleep has published five-year results from the remedē System Post Approval Study.
ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has acquired Respicardia, Inc., a provider of novel implantable neurostimulators for the treatment of moderate to severe Central Sleep Apnea (CSA).
Expanded insurance coverage now available in Pennsylvania, Delaware and West Virginia
Respicardia, Inc. announced today that Monument Health in Rapid City, South Dakota is the first center in the Dakotas to treat patients with the remedē® System, an implantable device that uses phrenic nerve stimulation to treat central sleep apnea (CSA).
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.
Trial results showed consistent improvement in sleep disordered breathing, arousals, sleep architecture, and daytime sleepiness through 5 years.
Respicardia, Inc. announced today that Richard L. Roudebush VA Medical Center in Indianapolis is the first center in Indiana to treat patients with the remedē® System, an implantable device that uses phrenic nerve stimulation to treat central sleep apnea (CSA).
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
A pooled analysis of the pilot and pivotal studies shows transvenous phrenic nerve stimulation (TPNS) significantly improves CSA severity, sleep quality, ventricular function, and QOL regardless of HF status
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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 info@respicardia.com.