Respicardia Also Initiates 500-Patient Prospective, Global, Single-Arm Longitudinal Study
MINNETONKA, Minn., July 10, 2019 /PRNewswire/ -- Respicardia, Inc., the manufacturer of the only FDA-approved active implantable device for the treatment of central sleep apnea (CSA), today announced the publication of the 24- and 36-month data from the remedē® System Pivotal Trial in the peer-reviewed journal SLEEP. The results demonstrate long-term safety and sustained improvement in sleep metrics from phrenic nerve stimulation in adult patients with moderate to severe CSA through 36 months of remedē System therapy.1
"It is imperative that we understand the long-term results of phrenic nerve stimulation since CSA and its underlying disorders are chronic and progressive," said Henrik Fox, MD, Senior Cardiologist at Ruhr-Universität Bochum, Bad Oeynhausen, Germany. "The durability of the clinical results seen in this trial further validates the remedē System as an effective, reliable, long-term treatment option for indicated patients."
Patients from the remedē System Pivotal Trial were assessed at 24 months (full overnight, in-lab, attended polysomnogram) and 36 months (home sleep study of cardiorespiratory polygraphy) to evaluate sleep metrics and safety. All sleep studies were scored by a central sleep core laboratory. The results at 24-months include:
- 99% reduction in the median of the central apnea index (CAI) from baseline
- 93% of patients had a reduction in the apnea-hypopnea index (AHI) from baseline
- 59% reduction in the median arousal index from baseline
- Improved rapid eye movement (REM) sleep and the percentage and minutes of sleep with oxygen saturation less than 90%, which is an independent predictor of all-cause mortality in chronic heart failure2
- 90% of patients were free from serious adverse events associated with the implant procedure, the remedē System or delivered therapy through 24 months. No additional related serious adverse events were reported between 24 and 36 months.
The control arm showed similar results once therapy was activated after a pre-specified 6-month randomization period. The improvement in sleep metrics for both groups was sustained and consistent at 36 months.
The latest results build upon prior published data in The Lancet and the American Journal of Cardiology which demonstrated that the remedē System significantly reduces the severity of CSA and improves sleep, quality of life and patient satisfaction,3 and the benefits are sustained.4
Along with the publication of this 3-year data, Respicardia also announced the initiation and first patient enrollments into a major new clinical study: the remedē System Therapy Study (rēST Study), a multi-center, prospective, open-label, single-arm study to collect safety and effectiveness data in approximately 500 remedē System patients in the United States and Europe for up to 5 years. To assess effectiveness, the study will evaluate changes in sleep metrics, daytime sleepiness, quality of life and, for patients with heart failure, core-lab determined cardiac remodeling biomarkers as well as functional capacity. The first global enrollments occurred July 9, 2019 at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina and were implanted by Dr. Michael N. Drucker who commented, "We are very excited to be leading the way and enrolling the first two patients into the rēST Study. Phrenic Nerve Stimulation has enormous potential to treat central sleep apnea patients who currently have few therapeutic options. The rēST Study will give us further insight into the impact of the therapy and long-term outcomes."
"We are dedicated to offering physicians and their patients a clinically proven CSA treatment option with long-term safety and benefits," said Peter Sommerness, President and CEO of Respicardia. "The 3-year data from the IDE Pivotal Trial combined with the initiation of the rēST Study further strengthens our clinical foundation and supports our commitment to improving patient outcomes."
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 quality of life and overall cardiovascular health. 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.
CMS granted the remedē System the New Technology Add-on Payment5 (NTAP) in August 2018 and the Transitional Pass-through Payment6 (TPT) in November 2018. The remedē system is the only technology to receive the TPT since 2015. These programs recognize innovative medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries.
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 visit www.respicardia.com, call +1-952-540-4470 or email firstname.lastname@example.org.
- Fox H, 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.
- Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, et al. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016;37(21):1695-703.
- Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82.
- 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.
- CMS-1694-F. FY2019 IPPS Final Rule. Vol. 83, No. 160 Pg. 41320.
- CMS-1695-FC. CY2019 OPPS Final Rule. Vol. 83, No. 225 Pg. 58939.
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