The world’s smallest defibrillation lead. Built for high reliability.
Built on the proven SelectSecure™ 3830 pacing lead platform,1,2 the OmniaSecure™ defibrillation lead is catheter-delivered to enable targeted lead placement — giving physicians the opportunity to reimagine what’s next in reliable therapy delivery.1
It takes an integrated, intricate, and indispensable network to make a heart beat. At Medtronic, we take our cues from biology itself. Only by working together can the body and the research and the technology move forward.
Restore
normal physiology
Restoring the normal physiology of our patients’ hearts with synchronized solutions and extensive evidence
Revolutionize
our patients’ experience
Revolutionizing our patients’ experience with therapies designed to be efficient, convenient, and accessible
Reimagine
what’s next
Reimagining what’s next through the power of AI, advanced algorithms, and transformed clinical workflows
We are unified in our mission to drive forward into the next era of electrophysiology.
Therapies and procedures
Atrial fibrillation (AF) management
Find out how exclusive innovations across our implantable devices and cardiac ablation portfolios can help you manage patients with or at risk of AF.
A defibrillator isn’t just a defibrillator. Learn about our full line of implantable cardioverter defibrillator (ICD) systems for treating your patients with tachyarrhythmias.
People are unique. Our cardiac resynchronization therapy (CRT) portfolio of devices is too. Our devices include a variety of comprehensive features to help tailor HF therapy for each of your patient’s needs.
Brief statement for LINQ II™ insertable cardiac monitor system (ICM) and accessories
Indications
The LINQ II™ ICM is an insertable automatically activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least two years old, in the following cases:
Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
Contraindications
There are no known contraindications for the insertion of the LINQ II™ ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Warnings and precautions
Patients with the LINQ II™ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the medical procedure and EMI warnings, precautions, and guidance manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the LINQ II™ MRI technical manual.
Accessories available for use with LINQ II™ ICM may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.
Potential adverse events or potential complications
Potential adverse events from the LINQ II™ ICM include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
There are no known adverse events associated with the use of any LINQ II™ ICM accessory.
See the device manuals for detailed information regarding the implant procedure, indications / intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 800-328-2518 (technical services) or 800-551-5544 (patient services).
Caution: Federal law (United States) restricts prescription devices to sale by or on the order of a physician.
MAJ_90968
Reveal LINQ™ ICM ISW
Brief statement for Reveal LINQ™ insertable cardiac monitor (ICM) system and accessories
Indications
The Reveal LINQ™ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain, that may suggest a cardiac arrhythmia.
The device has not been tested specifically for pediatric use.
Contraindications
There are no known contraindications for the implant of the Reveal LINQ™ ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
Warnings and precautions
Patients with the Reveal LINQ™ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ™ MRI technical manual.
Accessories available for use with Reveal LINQ™ ICM may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.
Potential adverse events or potential complications
Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
There are no known adverse events associated with the use of any Reveal LINQ™ ICM accessory.
See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at (800) 328-2518 (Technical Services) or (800) 551-5544 (Patient Services).
Caution: Federal law (United States) restricts prescription devices to sale by or on the order of a physician.
MAJ_90968
AccuRhythm™ AI Algorithms ISW
AccuRhythm AI ECG classification system brief statement
Indications: The intended use of the system is to reduce false positive cardiac arrhythmia episodes.
Contraindications: There are no known contraindications for AccuRhythm AI Models ZA400, ZA410, or ZA420.
Precautions: The AccuRhythm AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system.
See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic Technical Services at 800-328-2518 and/or consult Medtronic’s website atmedtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Crossley GH III, Sanders P, Hansky B, et al. Safety, efficacy, and reliability evaluation of a novel small-diameter defibrillation lead: Global LEADR pivotal trial results. Heart Rhythm. 2024;21(10):1914–1922. doi:10.1016/j.hrthm.2024.04.067.
Crossley GH, Sanders P, Filippo P, et al. Rationale and design of the lead evaluation for defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design. J Cardiovasc Electrophysiol. 2023;34(2):257–267. doi:10.1111/jce.15747.
