ZOLL Announces Approval of Next-Generation remedē System for the Treatment of Central Sleep Apnea (Transvenous Phrenic Nerve Stimulation)

CONTACT:

Matt Hogan

ZOLL Medical Corporation

ZOLL ANNOUNCES APPROVAL OF NEXT-GENERATION remedē SYSTEM FOR THE TREATMENT OF CENTRAL SLEEP APNEA (TRANSVENOUS PHRENIC NERVE STIMULATION)

The new remedē EL-X model delivers extended longevity, reduced size, and an enhanced suite of diagnostics

August 5, 2021 — CHELMSFORD, MASS. — ZOLL^® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the remedē^® EL-X System to treat moderate to severe Central Sleep Apnea (CSA) in adult patients.¹ CSA is a serious condition that is often associated with heart failure, coronary artery disease, and certain cardiac arrhythmias.

The next-generation remedē EL-X System combines enhanced functionality with a patient-friendly design, simplifying the implant procedure and providing greater device longevity for patients with Central Sleep Apnea. Features of the new device include:¹

Extended longevity: 40% longer average battery life versus previous version²
Reduced size: Approximately 25% smaller than the previous version
Simplified implant: Single lead, single-port system that provides both stimulation and sensing from a single lead
Data-driven clinical insights with DRēAM View: Enhancements include full-night, comprehensive diagnostic capabilities

"The next-generation remedē System is built on the proven success of the current platform, with the needs of both patients and clinicians in mind," said Pete Sommerness, President of ZOLL Respicardia. "The increased longevity, smaller size, enhanced diagnostics, and simplified implant procedure will substantially benefit patients."

"We are very excited to offer DRēAM View, a full-night diagnostic report that will allow clinicians deeper insight into how the patient is responding to remedē therapy," added Todd Goblish, Vice President of Research and Development at ZOLL Respicardia. "DRēAM View diagnostics will enable clinicians to better tailor therapy settings for each individual patient."

A phased launch of the remedē EL-X System will commence immediately in implanting centers in 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.³ The Post Approval Study followed patients from the pivotal trial through five years post implant.

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.⁴ Patients with CSA and heart failure are at increased risk for hospitalizations and even death.^5,6

About ZOLL Medical Corporation

ZOLL Medical Corporation, 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, and therapeutic temperature management, 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.

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 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.

¹ FDA PMA P160039, Supplement 006, Physician Manual.
² Under normal use settings
³ Costanzo M.R., et al. The Lancet. 2016;388:974–82.
⁴ Bekfani T, Abraham WT. Europace. 2016;18(8):1123–34. Epub 2016 May 26.
⁵ Khayat R, et al. J Card Fail. 2012;18:534–40.
⁶ Khayat, R et al. European Heart J. 2015;36 1463–69.

Copyright © 2021 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.

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