RESULTS

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 “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.