FDAnews
www.fdanews.com/articles/173690-medtronic-receives-ce-mark-for-new-icds
Medtronic Logo

Medtronic Receives CE Mark for New ICDs

October 21, 2015

Irish devicemaker Medtronic received the CE mark for its Visia AF and Visia AF MRI SureScan single-chamber implantable cardioverter defibrillators.

The devices can detect and monitor new onset, asymptomatic and previously undiagnosed rapid heartbeats, enabling physicians to better personalize treatment for patients, the company says.

Their algorithms capture atrial fibrillation burden frequency and duration and alert the physician from the patient's home.

The ICDs also feature a contoured shape with thin, smooth edges that reduces skin pressure by 30 percent, increasing patient comfort, Medtronic says. — Michael Cipriano