Female patient wearing the ASSURE WCD.

Welcome to ASSURE®

Welcome to ASSURE®

The ASSURE system is a modern approach to sudden cardiac arrest protection. It includes the ASSURE WCD, the ASSURE patient app and the Kestra CareStation® remote patient data platform, all working together as a digital healthcare system to empower your team.

Female patient wearing the ASSURE WCD.
Introducing

The ASSURE WCD

The ASSURE® Wearable Cardioverter Defibrillator (WCD) system from Kestra Medical Technologies provides important advantages based on patient-focused design and advanced technology.

WCDs work when patients wear them, with over 90% survival after an appropriate shock.¹,²,³ Yet providers report challenges when it comes to patient compliance.

Now, there’s a modern approach.

1 Wäßnig, N.K., et al. Circulation. 2016;134(9):635-43. 2 Ellenbogen, K.A., et al. JACC. 2017;3(3):243-250/. 3 Chung, M.K., et al. JACC. 2010;56:194-203.

Designed for Comfort & Compliance

HeartPoint Alert Button

Enables the patient to interact easily with the WCD—by hearing, feeling, and touching—all from an intuitive location on the body.

Designed for Comfort & Compliance

SensorFit Garments

Made of breathable, lightweight fabrics with nonadhesive, embedded, and cushioned ECG sensors that are designed to move with the patient and capture high-fidelity ECG signals.

Designed for Comfort & Compliance

ASSURE Monitor

The ASSURE Monitor features the ASSURE Detection Algorithm and includes:

Quad Channel Processing™ utilizes four channels of high-fidelity ECG to determine the patient’s heart rate and rhythm. Only one noise-free channel is required for rhythm analysis.

Adaptive Patient Intelligence™ is a proprietary technology that adapts to the patient’s heart rhythm to filter out artifacts caused by patient motion.

Female patient sitting comfortably while wearing the SensorFit Garments and monitor carry pack, with her hand positioned near the HeartPoint Alert Button for easy access.

ASSURE Wearable ECG

Data That Matters

The ASSURE Wearable ECG is a continued expansion of the ASSURE Cardiac Recovery System. The same SensorFit Garment and detection algorithm is offered in a small, non – therapeutic platform for patients who have completed their use of their ASSURE WCD. The ASSURE Wearable ECG provides an opportunity to continue patient monitoring via automatic episode storage, alert-based notifications, and physiologic trend data all uploaded to the Kestra CareStation remote patient data platform.

Patients and care teams can rest assured knowing that the ASSURE Assist service may be activated for post-event support.

Female patient wearing the SensorFit Garments with her finger placed over the HeartPoint Alert Button on the ASSURE WCD.

ASSURE Patient App

Empowering Patients in Their Recovery

Can automatically transmit patient heart rhythm data and lets patients monitor their usage time, track activity, and learn more about using the system.

Kestra Image

Dashboard view of the ASSURE Patient App on a patient's phone.

Kestra CareStation

Clear Patient Information Anytime, Anywhere

A remote patient data platform for the physician that offers efficient tools for managing cardiac patient care.

The Kestra CareStation platform delivers relevant data and valuable insights into patient heart rhythms and usage compliance:

  • Clear patient reports that include VT, VF, bradycardia, asystole, and non-sustained ventricular arrhythmia episodes.
  • WCD usage and physical activity trends.
  • Population dashboard with configurable notifications.
Physician accessing the Kestra CareStation remote patient data platform to review patient reports, heart rhythm data, and ASSURE WCD usage trends.

ASSURE Assist Service

Assurance When Needed

The ASSURE Assist® service1 is designed to connect patients to the assistance they need after a shock event. An Emergency Medical Services (EMS) operator attempts to contact the patient to determine if additional help is needed. If the patient cannot be reached, the EMS operator attempts to contact the patient’s emergency contact. If both the patient and the emergency contact cannot be reached, or if either request additional help, EMS may be dispatched to the patient’s location.

Important Information About the ASSURE Assist Service

1 The ASSURE Assist service requires the mobile device with the ASSURE patient app to be connected to the Internet and or Wi-Fi®, powered on, location services enabled with location permissions granted and within 30 feet of the ASSURE system for proper operation. In the event of an emergency, the ASSURE Patient App is not a substitute for appropriate medical attention and should not be relied on to contact emergency services. Kestra Medical Technologies Inc. (KMT) does not represent or warrant that the ASSURE Assist service prevents death, bodily or personal injury, or damage to you. KMT makes no representation of warranty as to the promptness of the ASSURE Assist service or emergency services. See important information about your ASSURE system at kestramedical.com/patients or the ASSURE Patient Application User Manual for a full explanation of service conditions and requirements.

Emergency responder vehicle illustrating the Emergency Medical Services (EMS) dispatch component of the ASSURE Assist service.
Emergency Medical Services (EMS) operator wearing a headset.

Freedom to Move

The ASSURE WCD offers patients the freedom to go about their daily lives during recovery with ease and confidence. The SensorFit Garments’ practical design and comfortable styling offer cardiac patients high reliability medical device protection while supporting normal patient activities.

Better compliance offers better protection.

Female patient wearing the discreet SensorFit Garments and monitor in the carrypack, illustrating the ASSURE WCD's practical design for patient comfort and freedom of movement.
PROVIDER PORTAL

Prescribe the ASSURE system

To prescribe the ASSURE® WCD, you’ll need to be registered in our portal.

  • Already registered? Click through to log in and get started right away.
  • Not registered yet? We can make it easy for you. Your Kestra rep can handle the set-up, or you can request access anytime.
Kestra Image

Need Help? We’re here for you.

Important Information About the ASSURE System

Indications for Use: The ASSURE system is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.

Contraindications: The ASSURE system is contraindicated for use on patients with an active implantable defibrillator.

Intended Use: The ASSURE system is intended for patients who have been prescribed this device by their physician.

Warnings:

The ASSURE system is not intended for use on patients with an implantable pacemaker that produces a pacemaker pulse artifact greater than 0.5 mV on any ASSURE system ECG channel. This artifact may interfere with the system’s ability to detect dangerous heart rhythms and prevent shock delivery.

Operating a motorcycle, boat, riding lawnmower, or other noisy vehicle, or any vehicle or equipment that emits heavy vibrations while wearing the ASSURE system may prevent the patient from realizing an alert is happening.

Keep the ASSURE system, Charger, and all accessories away from open flame, flammable gases, or other potential fire sources. Shock delivery in these environments may pose an explosion or fire hazard risk.

The ASSURE system is magnetic resonance (MR) unsafe. Do not wear or use this device near MR imaging equipment.

Do not place the Monitor, Therapy Cable, Charger, or Battery in water or other liquids. Avoid spilling any liquids on these devices. Liquids entering these devices may cause them to malfunction or fail.

Do not alter, drop, or abuse any part of the ASSURE system. Attempting to alter the equipment in any way may cause the device to malfunction or fail. Do not take apart the Monitor. Dangerous high voltages may be present. If service is required, call the ASSURE Helpline at (833) 692-7787 (toll free).

During use, do not stack or place the ASSURE system near other equipment. Doing so may cause the system to malfunction or fail due to EMI exposure from the other equipment. If such use is necessary, the ASSURE system and the other equipment should be observed to verify that they are operating normally.

Only use portable RF communications equipment that is included with or intended for use with the ASSURE system. Do not use any other portable RF communications equipment (including antenna cables and external antennas) any closer than 12 inches (30 cm) to any part of the system. Otherwise, equipment performance may suffer.