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Medtronic plc
today announced it
has received CE (Conformité Européenne) Mark for the Visia
AF(TM) and Visia AF MRI(TM) SureScan(R) single-chamber implantable
cardioverter defibrillators (ICDs), which can detect and monitor new
onset, asymptomatic, and previously undiagnosed atrial fibrillation
(AF). Early detection of AF can help a physician better tailor treatment
to the needs of the patient. The Visia AF devices include a proprietary
algorithm that accurately detects AF episodes, captures AF burden
frequency and duration(1) , and alerts the physician from the patient's
home.
An estimated 33 million people worldwide have AF, making it the most
common cardiac rhythm disorder in the world.(2) AF is a condition that
involves an irregular quivering or rapid heart rhythm in the upper
chambers (atria) of the heart, and patients with AF are five times more
likely to have a stroke(3) and three times more likely to have heart
failure.(4) Approximately 20 percent of patients who experience
ventricular arrhythmias (irregular heart rhythms in the lower chambers)
later develop AF(5) , which often goes undetected with traditional
external monitors.(6-7)
Built on the proven performance of the Medtronic Evera(TM) family of
ICDs, the Visia AF ICDs also feature a contoured shape with thin, smooth
edges that increases patient comfort by reducing skin pressure by 30
percent.(8) The devices include the same industry-leading battery
longevity (up to 11 years) compared to previous devices.(9-16) And when
paired with the Sprint Quattro(R) Secure MRI SureScan(R) DF4 leads -
part of the only ICD lead family with more than 10 years of proven
performance with active monitoring(17) - the Visia AF MRI SureScan
device allows patients to undergo full-body MRI scans.
The Visia AF ICDs include SmartShock(TM) 2.0, an exclusive shock
reduction algorithm that enables the device to better differentiate
between dangerous and harmless heart rhythms.(18) While the majority of
shocks delivered are necessary to treat potentially fatal arrhythmias,
studies estimate that approximately 20 percent of patients with
implantable defibrillators may experience inappropriate shocks in
response to a benign arrhythmia or electrical noise sensed by the
device.(19-22) SmartShock technology helps to eliminate these
inappropriate shocks, and delivers a 98 percent inappropriate shock-free
rate at one year.(23)
"Medtronic is committed to continuing to develop a wide range of
technologies to help patients with AF," said Marshall Stanton, M.D.,
vice president and general manager of the Tachycardia business, which is
part of the Cardiac Rhythm and Heart Failure division at Medtronic.
"With devices like the Visia AF ICDs and the Reveal LINQ(TM) Insertable
Cardiac Monitor, which detects and monitors abnormal heart rhythms for
up to three years, we aim to increase AF detection and enable physicians
to manage a patient's risk for strokes and heart failure."
In the U.S., the Visia AF ICDs are not yet approved for commercial use.
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. The company strives to
offer products and services that deliver clinical and economic value to
healthcare consumers and providers around the world.
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