Heart Protection that Wears Well
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.
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.
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.
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.
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.
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.
Personalized Fitting and Training
When receiving an ASSURE system, a Kestra trained patient service representative will correctly size your SensorFit Garments and train you to assemble, wear, and properly use the system. The representative will answer any questions and make sure you fully understand the system.
Kestra Care is With You
After returning home, the Kestra Care™ team is ready to assist. Call the ASSURE Helpline anytime at (833) 692-7787 (toll free).
Returning the ASSURE system
After a doctor has determined that the ASSURE system is no longer needed, returning it is as easy as packing up the system and calling the ASSURE Helpline at (833) 692-7787 (toll free) to schedule pickup.
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.
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.
ASSURE Patient Training Video
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.
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.
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.