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Biotronik’s Sentus ProMRI bipolar lead gets CE mark clearance

Biotronik has announced the European approval and the first implantations of its bipolar cardiac resynchronization therapy lead Sentus ProMRI.

The new CRT lead, which received CE mark approval in early February 2014, is claimed to be the first MR conditional lead with a 4F diameter — approximately 1.6mm.

This ultra-thin lead allows clinicians with more pacing options to access hard-to-reach vessels. In addition to these important therapeutic benefits, the Sentus lead allows cardiac failure patients with a CRT implant to safely undergo MRI (magnetic resonance imaging) scans.

Heart failure is associated with a dyssynchronos contraction pattern of the heart ventricles, which can be treated with CRT.

However, as heart failure patients are often in poor general health and over the age of 65 and often suffer from comorbidities that may require an MRI scan such as stroke, brain tumors, and arthritis.

According to the company, there is an estimated 50 to 75% probability that patients will be indicated for an MRI over the lifetime of their device.

With Biotronik home monitoring system, the new CRT lead has demonstrated a reduction in all-cause mortality in heart failure patients in the IN-TIME study. The clinical studies have shown CRT’s effectiveness in reducing the risk of heart failure events and rehospitalization.