Recover
with Confidence
Heart Protection that Wears Well
✓ Comfort ✓ Connection ✓ Confidence
The ASSURE® system is the modern approach to protecting patients at risk of Sudden Cardiac Arrest (SCA).
It incorporates what we’ve learned from listening closely to patients and doctors.
Patients expressed the need to feel confident, connected to their healthcare team, and protected during their recovery. Equally, they wanted a system that was simple to use, comfortable to wear, and easily hidden under clothing.
Welcome to ASSURE.
ASSURE Patient Training Video
Why am I Being Prescribed a Wearable Defibrillator?
Your healthcare team has prescribed a wearable defibrillator because your current condition may put you at risk for abnormal heart rhythms that can disrupt normal blood flow, commonly known as arrhythmias. Certain arrhythmias can be life-threatening and increase the risk of SCA.
What is Sudden Cardiac Arrest?
Sudden Cardiac Arrest (SCA) happens when an electrical malfunction in the heart causes a ventricular arrhythmia that results in the heart not pumping blood sufficiently throughout the body, which can lead to loss of consciousness and even death if not treated quickly.
Wearable defibrillators (WCDs) are a recommended treatment for monitoring and protecting patients with a low ejection fraction (EF), a measure of how well the heart is pumping blood. An EF of 35% or below is considered very low¹. A low EF percentage indicates weakened or damaged heart muscles that do not pump blood efficiently and increases the risk of SCA.
WCDs continuously monitor a patient’s heart rhythm. If a potentially life-threatening arrhythmia is detected, the WCD first alarms the patient and then safely administers a defibrillation shock in order to return the patient’s heart rhythm to normal.
1 https://my.clevelandclinic.org/health/articles/16950-ejection-fraction
What are Ventricular Tachycardia and Ventricular Fibrillation?
Both ventricular tachycardia (VT), a very fast heartbeat, and ventricular fibrillation (VF), a disorganized heartbeat, are forms of arrhythmias that can be life-threatening and result in SCA.
If a heart goes into VT or VF, rapid defibrillation is crucial, as chances of survival decrease about 10% with each passing minute.²
The ASSURE system can detect these arrythmias and, if needed, quickly and automatically deliver appropriate defibrillation to restore normal heart rhythm.
2 https://stopcardiacarrest.org
What is Defibrillation?
When a heart is in a dangerous rhythm such as ventricular fibrillation, a defibrillator can provide effective therapy. A defibrillation shock sends a burst of energy through the heart to reset its natural pacemaker to return to a normal rhythm.
Wearable defibrillators can offer support and protection during cardiac recovery. They are worn underneath regular clothing and can automatically detect SCA and safely deliver a defibrillation shock, even when a patient is alone or asleep.
The ASSURE system from Kestra Medical Technologies is a modern wearable defibrillator designed to be comfortably worn for a temporary period to protect against SCA. It can protect you while you wear it, day or night, even when alone. And it can provide important information to help support your recovery.
Other types of defibrillators include automated external defibrillators (AEDs) often seen in public spaces. They are highly effective but require a medical professional or bystander to be present to use the device. Internal defibrillators, or implantable cardioverter defibrillators (ICDs), are small, implanted devices attached to the heart. An ICD can deliver defibrillation rapidly and does not require manual assistance. If your doctor determines you are a candidate for an ICD, there is often a waiting period before one can be implanted.
Patient Stories
Meet real patients and learn about how the ASSURE system provided them protection during their recovery.
“Without wearing that .... I wouldn't be here.”
Randy
“This is the greatest gift you guys gave me, that’s how I look at it.”
“If I have a problem, the device will start talking to me.”
Easy to Use
The ASSURE wearable defibrillator is easy to use and maintain so patients and their caregivers can focus on recovery.
The HeartPoint™ Alert Button provides a simple way of interacting with the system—by hearing, feeling, and touching—all from an intuitive location on the body.
Connectivity that Works for Everyone
The ASSURE patient app automatically transmits data at certain intervals or when the patient chooses to transmit, via the ASSURE patient application and the Kestra CareStation™ remote patient data platform. It makes the information available to doctors and healthcare professional teams* to enable appropriate adjustments to treatment if needed. The app helps you participate in your own recovery with activity and hours worn monitoring. For privacy and protection, all the data is encrypted.
*The ASSURE patient app (optional) is installed on a mobile device that is provided with the ASSURE system. Patients should ensure the mobile device is connected to Wi-Fi® or cellular service when using the ASSURE patient app.
Freedom to Move
SensorFit™ Garments are designed to ensure optimal comfort and performance. They are breathable and lightweight with integrated, cushioned electrocardiogram sensors, and hold the defibrillation therapy pads.
Styled and engineered by leading athletic and sportswear designers, SensorFit Garments are tailored in two styles and a wide range of sizes and can be machine washed.
A Powerful Companion at Your Side
The ASSURE Monitor analyzes heart rhythms, detects arrythmias and provides safe defibrillation if needed. It features advanced technology, including the ASSURE Detection Algorithm with Quad Channel Processing™ and Adaptive Patient Intelligence™.
The Carry Pack can be worn easily clipped to a belt, around the waist, or over the shoulder.
Continued Recovery with Confidence
At the end of WCD use, your doctor may prescribe the Wearable ECG to continue monitoring the state of your heart. It is a non-therapeutic device, meaning your doctor believes you are at a lower risk of Sudden Cardiac Arrest, but would like to continue evaluating your heart rates and rhythms.
The Wearable ECG is shipped directly to your door. Using the same SensorFit Garments and patient app, you can follow set up instructions from the comfort of home. The Wearable ECG continues to collect data about your heart and send it wirelessly to your doctor via the Kestra CareStationTM remote patient data platform.
Rest assured knowing that the ASSURE Assist service may be activated for post-event support.
Living with the ASSURE System
Assurance When You Need It
If a shock occurs while wearing the ASSURE system, the ASSURE Assist® service attempts to contact you and your emergency contact, then emergency services, via the ASSURE patient app to determine if additional support is needed.*
*The ASSURE Assist service requires a smartphone 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 in the Patient Handbook and important information about the ASSURE Assist service in the Patient Application User Manual for a full explanation of service conditions and requirements.
Information for Family and Caregivers
Caring for a loved one experiencing a heart condition can be challenging. The ASSURE Wearable Defibrillator Patient Handbook contains important information about how to use the system. Here are a few things to always keep in mind:
- THE PATIENT IS THE ONLY PERSON who should press the HeartPoint Alert Button. Do not press the Alert Button for them, as this may interfere with lifesaving treatment.
- Following a shock, the ASSURE system will instruct anyone nearby to call 911. Do so immediately. The system will not call 911 for you.
Why is it Important that I Wear My ASSURE System?
The ASSURE system offers protection from SCA and peace of mind when correctly worn. It is designed to be as comfortable as possible so it can easily fit into your lifestyle.
Wearable defibrillators save lives. In several studies, more than 90% of patients who received an appropriate shock from their wearable defibrillator survived to be discharged from the hospital.³
Importantly, wearable defibrillators only work when they are worn. That’s why it is vital to wear your ASSURE system as close to 100% of the time as possible, removing it only to bathe, shower, or engage in water activities like swimming.
Wearing your ASSURE system can help you feel confident, supported, and protected throughout your recovery.
3 Epstein AE, et al. JACC 2013 4 Chung, M.K., et al. JACC. 2010;56:194-203.
Go
Anywhere
with
Confidence
Patient Resources
Important Information About Your 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:
Do not place the Monitor, Therapy Cable, Charger, or Battery in water or other liquids. Avoid spilling any liquids on these devices. Exposure to liquids may cause devices to malfunction or fail. Follow the instructions provided with the devices to properly clean these devices.
If you will be away from home for longer than 24 hours, take the spare, fully charged Battery and Charger with you.
During use, do not stack or place the ASSURE system near other electronic equipment. Doing so may cause the system to malfunction or fail due to electromagnetic interference 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 radio frequency (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.
When washing the Garment, do not use chlorine bleach, bleach alternatives, fabric softeners, or anti-static sprays. In addition, do not use detergents or detergent “pods” that include bleach or fabric softener additives.
Do not connect line voltages, power banks, or other devices that may attempt to use the USB port on the Charger as an input port. The Charger’s USB port is a dedicated charging port that is Output Only and must be used solely to charge connected devices. Always remove the Therapy Cable before washing the Garment.
If the Plug is removed from the Monitor and then reinserted while the ASSURE system is operational, the system may issue the Connect Plug to Monitor alert repeatedly. This alert will continue to play even if the Plug is removed and re-inserted into the Monitor. If this occurs, remove the Battery from the Monitor, and then re-insert it to restart the ASSURE system.