First 4 French MRI Conditional Lead Granted CE Mark


March 6, 2014
Biotronik Home Monitoring CRT Leads, Implantable Devices EP Lab

March 6, 2014 — Biotronik announced the first implantations of the Sentus ProMRI lead. Biotronik’s bipolar cardiac resynchronization therapy (CRT) lead is the first MR conditional lead with a 4 French diameter — approximately 1.6 mm. An ultra-thin lead, it enables access to particularly challenging vessels and offers expanded pacing options. In addition, the Sentus leads are allow patients to undergo MRI (magnetic resonance imaging) scans. The CRT lead received CE marking in early February.

As heart failure patients are often in poor general health and over the age of 65, it is particularly important that they have MRI access. Furthermore, patients at this age frequently suffer from comorbidities that may require an MRI scan such as stroke, brain tumors and arthritis. This increasing demand leads to an estimated 50 to 75 percent probability that patients will be indicated for an MRI over the lifetime of their device.

Philippe Ritter, M.D., Bordeaux University Hospital, France, said, "Biotronik ProMRI leads and implantable devices allow me to offer my heart failure patients reliable therapy, enhancing their quality of life."

"With Biotronik Home Monitoring, I can continuously monitor a therapy's effectiveness and react quickly if the patient's condition changes or deteriorates," said Christof Kolb, M.D., German Heart Centre, Munich, Germany. "This is particularly important for heart failure patients, as their status can change quickly and often."

Clinical studies have shown CRT's effectiveness in reducing the risk of heart failure events and rehospitalization. The IN-TIME study demonstrated a reduction in all-cause mortality in heart failure patients with Biotronik Home Monitoring.

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