CLINICAL EVIDENCE STROKE CARE
Setting new standards of care and driving economic value.
STANDARD OF CARE
The AHA/ASA guidelines1 recommend the use of endovascular treatment with stent retrievers, like the Solitaire™ device, following
IV t‑PA for eligible patients experiencing acute ischemic stroke (AIS).
ACUTE ISCHEMIC STROKE
Studies prove the Solitaire™ revascularization device reduces stroke-related disability in patients suffering large vessel AIS following
IV t-PA.2-6
SUPPORTED BY GUIDELINES
ESC Atrial Fibrillation Guidelines recommend long-term cardiac monitoring for cryptogenic stroke patients.7
SEE THE GUIDELINES
LONG-TERM CARDIAC MONITORING
Reveal™ insertable cardiac monitoring is superior to standard monitoring for AF detection.8
READ STUDY RESULTS
1
Powers WJ, Derdeyn CP, Biller J, et al. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients with Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals from the American Heart Association/American Stroke Association. Stroke. Oct 2015;46(10):3020-3035.
2
SWIFT PRIME- Saver JL, Goyal M, Bonafe A, et al. Stent-retriever thrombectomy after intravenous t‑PA vs. t‑PA alone in stroke. N. Engl. J. Med. Jun 11 2015; 372(24):2285-2295.
3
EXTEND-IA- Campbell BC, Mitchell PJ, Kleinig TJ, et al. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N. Engl. J. Med. Mar 12 2015; 372(11):1009-1018.
4
ESCAPE- Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N. Engl. J. Med. Mar 12 2015; 372(11):1019-1030.
5
REVASCAT - Jovin TG, Chamorro A, Cobo E, et al. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N. Engl. J. Med. Jun 11 2015; 372(24):2296-2306.
6
MR CLEAN - Berkhemer OA, Fransen PS, Beumer D, et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N. Engl. J. Med. Jan 1 2015; 372(1):11-20.
7
Kirchhof P, Benussi, S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. doi:10.1093/eurheartj/ehw210.
8
Sanna T, Diener HC, Passman RS, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF). N Engl J Med. 2014; 370(26):2478-2486
REVEAL LINQ™ LNQ11 Insertable Cardiac Monitor
Indications
The Reveal LINQ Insertable Cardiac Monitor 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.
Patient Assistant
The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal Insertable Cardiac Monitor to initiate recording of cardiac event data in the implanted device memory.
Contraindications
There are no known contraindications for the implant of the Reveal LINQ Insertable Cardiac Monitor. However, the patient's particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
Warnings/Precautions
REVEAL LINQ™ LNQ11 Insertable Cardiac Monitor
Patients with the Reveal LINQ Insertable Cardiac Monitor 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.
Patient Assistant
Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device.
Potential Complications
Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic's website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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