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CE approval of the first 4F MR conditional lead

Manufacturing Group | March 11, 2014

An ultra-thin lead, it enables access to particularly challenging vessels and offers expanded pacing options.

CE approval of the first 4F MR conditional lead

Berlin, Germany – BIOTRONIK officials 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 4F diameter – approximately 1.6mm. An ultra-thin lead, it enables access to particularly challenging vessels and offers expanded pacing options. In addition to these important therapeutic benefits, the Sentus leads are unique in that they allow patients to undergo MRI (magnetic resonance imaging) scans. The new CRT lead received European market (CE) approval 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% probability that patients will be indicated for an MRI over the lifetime of their device.1

As Philippe Ritter, MD, Bordeaux University Hospital, France, commented, “Heart failure patients require complex disease management. Particularly as patients age and develop comorbidities, they may need an MRI scan—the gold standard for soft tissue imaging. 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, MD, German Heart Centre, Munich, Germany. “This is particularly important for heart failure patients, as their status can change quickly and often.”

Heart failure therapy
Heart failure is a complex disease characterized by the progressive weakening of the cardiac muscle. Approximately one to two percent of the adult population in developed countries has heart failure. Among those 70 and older, the prevalence rises to about ten percent.2 The disease is associated with a dyssynchronous contraction pattern of the heart ventricles, which can be treated with CRT. Clinical studies have shown CRT’s effectiveness in reducing the risk of heart failure events and rehospitalization.3 The IN-TIME study demonstrated a reduction in all-cause mortality in heart failure patients with BIOTRONIK Home Monitoring.4

Source: BIOTRONIK

References:

1 Roguin et al., Europace (2008), 10 (3): 336-346.

2 European Heart Journal (2012), 33: 1787-1847.

3 Moss et al., New England Journal of Medicine (2009), 361: 1329-38, and Anand et al., Circulation (2009), 119: 969-977.

4 Results presented Sept. 2013 at the European Society of Cardiology conference.

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