Modern Wearable Cardiac Protection
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.
- Wäßnig, N.K., et al. Circulation. 2016;134(9):635-43.
- Ellenbogen, K.A., et al. JACC. 2017;3(3):243-250/.
- Chung, M.K., et al. JACC. 2010;56:194-203.
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.
Designed for What Matters Most:
✓ Compliance
✓ Clarity
✓ Confidence
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.
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.
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.
Freedom from False Positive Shock Alarms
94% of ASSURE system patients never experience a false alarm
Disclaimer: A controlled, head-to-head study evaluating the comparative performance of these devices has not been done.
1. ACE-PAS (NCT05135403, n = 5,929). Data on file. 2. Arkles, J. et al. J Interv Card Electrophyiol. 2023;66(7):1723-1728
SensorFit™ Garment design helps optimize patient protection, resulting in median wear time >23 hours/day¹
First shock success rate is >95%¹
1. ACE-PAS (NCT05135403, n = 5,929). Data on file. 2. Arkles, J. et al. J Interv Card Electrophyiol. 2023;66(7):1723-1728
Provider Viewpoints
"Patients are more apt to wear it, and wear it regularly."
“Having a device to protect people during that vulnerable period is an important feature to be able to offer to your patients.”
"They all think it’s much more comfortable, they’re compliant, and it was a service to give it to them.”
Data That Matters
ASSURE Wearable ECG
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.
Clear Patient Information Anytime, Anywhere
Kestra CareStation
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.
Empowering Patients in Their Recovery
ASSURE Patient App
Can automatically transmit patient heart rhythm data and lets patients monitor their usage time, track activity, and learn more about using the system.
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.
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.
Provider Resources
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.