Expanded insurance coverage now available in Utah, Idaho and Nevada
September 20, 2022
MINNETONKA, MINN. – ZOLL Respicardia, a division of ZOLL® Medical Corporation, announced that SelectHealth and its affiliates will provide coverage for the remedē® System therapy, effective immediately. SelectHealth provides health insurance coverage to over one million individuals across Utah, Idaho and Nevada.
With the addition of the SelectHealth coverage policy, the remedē® System is now included in commercial insurance coverage policies that represent over 29 million covered lives and also is available at VA facilities across the United States.
The remedē System and Central Sleep Apnea
The first-generation remedē System was approved by the FDA in 2017. The remedē 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 help restore a normal breathing pattern.1
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. Many patients with CSA also have heart disease, especially heart failure.2 Patients with CSA and heart failure are at increased risk for hospitalizations and even death.3,4
IMPORTANT SAFETY INFORMATION
Indications for Use
The remedē® System is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients.
Contraindications
The remedē System is contraindicated for the following:
- Patients with an active infection
- Patients known to require magnetic resonance imaging (MRI)
Warnings
- Diathermy — Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively referred to as diathermy) on patients implanted with the remedē System.
- Electric Shock — When operating under AC power, the remedē System Programmer must be connected to a grounded power source to avoid risk of electric shock.
- Concomitant Active Implantable Devices — Use the remedē System with caution in patients with an active implantable device that may be susceptible to unintended interaction with the remedē System. Consult Respicardia to assess the possibility of interaction.
- Patients with Evidence of Phrenic Nerve Palsy — Therapy with the remedē System may be ineffective in patients who have evidence of phrenic nerve palsy.
- Pediatric Use — The safety and effectiveness of the remedē System has not been established for pediatric use.
Precautions
It is recommended that testing for oversensing of remedē stimulation therapy by the concomitant cardiac device occur at the time of implant and prior to initiating remedē System therapy in patients with a concomitantly implanted cardiac device. Use remedē System therapy with caution in pacemaker-dependent patients without a physiologic escape rhythm. Device interaction may lead to over or undersensing resulting in a loss of pacing. The safety and effectiveness of the remedē System during pregnancy has not been established.
See the Device Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.
Adverse Effects
Possible adverse events which may be associated with the use implantation and use of the remedē System include, but are not limited to, the following: adverse contrast dye reaction such as allergic reaction, pulmonary edema, or worsening renal function, adverse reaction to radiation exposure, thromboembolism, air embolism, bleeding, cardiac perforation including tamponade, hematoma, seroma, local bruising or swelling, hypotension, local wound healing issues at device implant site including wound dehiscence, pocket erosion, extrusion, movement of implanted device, keloid formation, pneumothorax, hemothorax, vascular damage, e.g., venous dissection, perforation, adverse biocompatibility reaction to the implanted system, infection, lead breakage, lead dislodgement, lead not connected or secured appropriately in device header, implantable device malfunction, requirement for more energy to stimulate the nerve or ineffective stimulation, venous occlusion, crosstalk with another implanted device, disrupted sleep, muscle fatigue or discomfort in diaphragm, chest or abdomen from appropriate stimulation, nerve dysfunction, perturbation of blood gases causing hypoxia, hypercapnea and/or hypocapnea, inappropriate sensations, worsening heart failure, respiratory status or overall health, anxiety, arrhythmia, including ventricular fibrillation, death, depression, hypotension, pain, skin irritation or local allergic reaction, thrombus or embolism, potentially leading to pulmonary embolism or stroke.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
- Costanzo M.R., et al. The Lancet. 2016;388:974–82.
- Bekfani T, Abraham WT. Europace. 2016;18(8):1123–34. Epub 2016 May 26.
- Khayat R, et al. J Card Fail. 2012;18:534–40.
- Khayat, R et al. European Heart J. 2015;36 1463–69.