Roudebush L. Roudebush VA Medical Center performs remedē first System implant in Indiana
MINNETONKA, Minn. – June 1, 2020 – Respicardia, Inc. announced today that Richard L. Roudebush VA Medical Center in Indianapolis is the first center in Indiana to treat patients with the <strong>rem</strong>edē® System, an implantable device that uses phrenic nerve stimulation to treat central sleep apnea (CSA). Dr. Mohamed Homsi, cardiac electrophysiologist, treated two patients with CSA during back-to-back procedures performed on May 5, 2020. Patients were referred from sleep medicine by Dr. Adam Lenet and Dr. Ninotchka Sigua.
“We are committed to offering advanced technologies and finding patients the best care,” says Dr. Homsi.
“We have patients who suffer from central sleep apnea who have limited treatment options or have persistent sleep apnea despite PAP therapy. We now have another option for our Veterans. Both patients had struggled to find an effective therapy and were outstanding candidates for this system,” adds Dr. Sigua.
The <strong>rem</strong>edē 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 <strong>rem</strong>edē System was approved for moderate to severe CSA in adult patients by the U.S. Food and Drug Administration (FDA) in 2017.2 It was added to the Government Services Administration (GSA) Federal Supply Schedule (FSS) in 2018, making it available within the VA system. The Indianapolis VA Medical Center is the third VA in the country to offer the <strong>rem</strong>edē System, joining Houston and Iowa City VA Medical Centers.
“We are eager to partner with the medical center team to bring this therapy to more Veterans who will benefit,” said Peter Sommerness, President and CEO of Respicardia.
About Central Sleep Apnea (CSA) and the <strong>rem</strong>edē® 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.3,4
The <strong>rem</strong>edē 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 were published in Sleep in July 2019.5
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.
5 Fox H, Oldenburg O, Javaheri S, et al. <strong>rem</strong>edē® 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.
Important Safety Information
The <strong>rem</strong>edē 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 <strong>rem</strong>edē System is right for you. You will not be able to have an MRI or diathermy (special heat therapies) if you have the <strong>rem</strong>edē System implanted. The <strong>rem</strong>edē 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 <strong>rem</strong>edē 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 <strong>rem</strong>edē 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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