CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the United States Food and Drug Administration (FDA) has approved the remedē System for conditional use with magnetic resonance imaging (MRI). ZOLL’s remedē System is an implantable transvenous phrenic nerve stimulation therapy for the treatment of adults with moderate to severe Central Sleep Apnea (CSA). Full-body MRI approval applies to all models of remedē System, covering new remedē patients as well as those who already have a remedē device.
“Patients with Central Sleep Apnea often suffer from other co-morbidities that may benefit from MRI scanning including, but not limited to, brain, spine and joint issues. Approval of the remedē System for conditional use with MRI will allow those patients to now have access to this important therapy,” said Dr. Asim Roy, medical director of the Ohio Sleep Medicine Institute.
“MRI compatibility for the remedē System has a substantial positive impact for both patients and providers. Access to a wider range of imaging options is important to ensuring patients receive the best care available,” said Collin Anderson, President of ZOLL Respicardia. “Prior to this approval, the need for ongoing MRI was a contraindication for the remedē System and a concern for patients who were uncertain about their long-term healthcare needs. FDA approval to use full-body MRI on remedē patients is a significant milestone for ZOLL and the remedē therapy.”
The 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 more normal breathing pattern.1
The next-generation remedē EL-X System, approved by the FDA in 2021, combines enhanced functionality with a patient-friendly design, simplifying the implant procedure and providing greater device longevity for patients with Central Sleep Apnea. Features include longer average battery life, reduced size, stimulation and sensing from a single lead, and full-night, respiration and device algorithm monitoring capabilities via DRēAM View.
About Central Sleep Apnea
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
About ZOLL
ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.
About Asahi Kasei
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.
Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability.
Copyright © 2023 ZOLL Medical Corporation. All rights reserved. ZOLL, Respicardia, and remedē are registered or unregistered trademarks of ZOLL Medical Corporation and/or its affiliates in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.
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
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The remedē System is contraindicated for the following:
- Patients with an active infection
Warnings
- The device is MR Conditional. The conditions and precautions can be found in the remedē System manual.
- 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 remedē System with caution in patients with an active implantable device that may be susceptible to unintended interaction with the remedē System.
- 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 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: Rx only. Prior to use, please see the complete “System Implant and Clinician Use Manual” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
The remedē® System, remedē® EL System, and remedē® EL-X System have received FDA approval. The remedē® System model 1001 has received CE Mark approval.
MKT3159 Rev C.
1 Costanzo M.R., et al. The Lancet. 2016;388:974–82.
2 Bekfani T, Abraham WT. Europace. 2016;18(8):1123–34. Epub 2016 May 26.
3 Khayat R, et al. J Card Fail. 2012;18:534–40.
4 Khayat, R et al. European Heart J. 2015;36 1463–69.
