In the United States, cryoablation is FDA-approved for patients with drug refractory, recurrent, symptomatic, paroxysmal AF; it is not approved for patients with persistent AF. Cryoablation has been shown to deliver better outcomes in paroxysmal AF patients for whom at least one drug therapy has previously failed. Worldwide, the system has been used to treat more than 120,000 patients in approximately 1,000 centers across 50 countries.
About Medtronic's Symplicity Spyral Catheter and G3 Generator
Medtronic's renal denervation technology consists of the Symplicity Spyral multi-electrode catheter and the Symplicity G3(TM) RF Generator. Treatment involves a minimally invasive endovascular procedure, where the physician inserts the small, flexible Spyral catheter into the femoral artery in the upper thigh and threads it into both renal arteries in turn. Once the catheter is in place within the renal artery, the G3 generator is activated to deliver controlled, low-power radio-frequency (RF) energy, according to a proprietary algorithm aiming to deactivate the surrounding renal nerves for the goal of reducing the increased activity of the sympathetic nervous system. The Spyral catheter uniquely offers physicians control and flexibility with the ability to turn specific electrodes on and off to accommodate different anatomies. The next generation system is based on Medtronic's single-electrode Symplicity renal denervation system, which has an established safety profile.
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About Medtronic's Reveal LINQ Insertable Cardiac Monitor (ICM)
Cleared by the Food and Drug Administration (FDA) in 2014, the Reveal LINQ ICM System is the newest generation of ICM and the smallest cardiac monitor available (~1 cc, or one-third the size of a AAA battery). Common uses include monitoring syncope patients for potential episodes of bradycardia/asystole, monitoring cryptogenic stroke (strokes of unknown cause) patients for possible episodes of AF, and monitoring patients suffering from intermittent chest palpitations for potential episodes of atrial or ventricular arrhythmias. The Reveal LINQ ICM is inserted under the skin of the chest (incision less than 1-cm), and its battery allows for up to three years of monitoring. Additionally, the device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink® Network.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
