Journal of Clinical Sleep Medicine publishes pooled safety and efficacy data from remedē studies
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
MINNETONKA, Minn. – January 20, 2020 – The December issue of The Journal of Clinical Sleep Medicine (JCSM) features a pooled cohort analysis of efficacy and safety data for patients treated with the remedē system in the pilot and pivotal studies. The publication included 208 patients (n=57, Pilot; n=151, Pivotal) with moderate to severe CSA, 68% of whom had comorbid heart failure (HF) that was not ACC/AHA Heart Stage D (exclusion criteria). Both studies were prospective, multicenter trials with sleep assessments performed using polysomnography (PSG) and interpreted by a central sleep laboratory. While the trials did not prospectively study the impact of the remedē system in heart failure patients or on heart failure symptoms, LVEF was included as a secondary endpoint. The results demonstrate transvenous phrenic nerve stimulation (TPNS) significantly improves central sleep apnea (CSA) severity, sleep quality, ventricular function, and QOL.
“Phrenic nerve stimulation induces a breathing pattern through diaphragmatic stimulation with resultant negative intrathoracic pressures. As a result, the more physiologic breathing patterns with phrenic nerve stimulation are less likely to exert adverse effects on central hemodynamics as is seen with positive airway pressure ventilation. The improvements in subjective and objective parameters such as LVEF are very encouraging and consistent with this physiology. Moreover, the therapy automatically activates each night without patient interaction, which maximizes the duration of the night time therapy,” says Dr. Marat Fudim, Division of Cardiology, Duke University Medical Center.
Key findings from the analysis include:
- 95% device implant success rate with improvements in implant success and efficiency in the second trial
- Substantial decrease in CSA burden paralleled by significant improvements in arousal index, time spent with oxygen saturation < 90%, daytime sleepiness, REM sleep, cardiac function, and QOL measures
- In patients with HF, HF symptoms improved at 6 months and in the subgroup with LVEF ≤ 45%, cardiac function improved at 12 months
- All benefits of phrenic stimulation observed at 6 months were sustained at 12 months
- Safety events were experienced by 14% of the pooled group, improving from 30% in pilot to 9% in pivotal with the reduction due in large part to the introduction of new stimulation lead models that were easier to anchor in the vessel.
“These results demonstrate the safety and effectiveness of TPNS across two separate studies. Respicardia is committed to continuing to publish data on the consistency and durability of the patient response to TPNS” adds 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 firstname.lastname@example.org.
# # #
Vice President, Marketing