HF Cohort

Due to safety concerns associated with some mask-based therapies for patients with heart failure and reduced left ventricular ejection fraction (LVEF), post-hoc analysis was performed on the heart failure cohort from the Pivotal Trial.

Patients with both heart failure and central sleep apnea comprise over half (68%) of patients studied in the remedē® System Pilot and Pivotal studies. In post-hoc analysis, the heart failure cohort demonstrated similar sleep and quality of life improvements to that of the full population.1,2

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1. Costanzo MR, et al. European Journal of Heart Failure 2018; doi:10.1002/ejhf.1312.
2. Fudim M, Spector AR, Costanzo MR, et al. J Clin Sleep Med. 2019;15(12):17471755.
3. Ponikowski P, et al. Eur J Heart Fail 2019;21 (S1): 346; doi:10.1002/ejhf.1488

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for remedē®?

The following data is intended to address questions raised by clinicians about how patients with heart failure and reduced ejection fraction responded when their moderate to severe CSA was treated with remedē.  These questions frequently arise due to safety concerns when other CSA therapies are applied to patients with heart failure and reduced ejection fraction.

 

Importantly, please note that these studies may involve findings that are not contained within the remedē System manual. The intent of providing these data is to disseminate up-to-date scientific findings about the remedē System to clinicians. Please refer to the studies cited to understand the strengths and limitations of the data.

 

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For Patients

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 call +1-952-540-4470 or email info@respicardia.com.