Biotronik’s MR Conditional Lead Awarded CE Approval

Biotronik, a leading manufacturer of cardiovascular medical technology specialising in heart failure therapy, has announced the first implantations of the Sentus ProMRI lead.

Biotronik’s bipolar cardiac resynchronisation therapy (CRT) lead is the first MR conditional lead with a 4F diameter, equivalent to approximately 1.6 millimeters. Having received European market (CE) approval in early February, this ultra-thin Sentus leads CRT lead is enabling access to particularly challenging vessels and offering expanded pacing options. 

Additionally, it allows patients to undergo MRI (magnetic resonance imaging) scans, a benefit of great importance to heart failure patients who are often in poor general health, over the age of 65 and susceptible to suffering frequently 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, MD of France’s Bordeaux University Hospital, explained that heart failure patients necessitated complex disease management, especially in view of their advanced age and increased need for MRI. He went on to say that the Biotronik ProMRI leads and implantable devices allowed him to provide his heart failure patients with reliable therapy while enhancing their quality of life.

Christof Kolb, MD, of Munich’s German Heart Centre, agreed that the Biotronik Home Monitoring enabled him to continuously monitor a therapy's effectiveness and react quickly if the patient’s condition changed or even deteriorated, a fact that was vital due to the fact that heart failure patients’ status could change quickly and frequently. 

Heart Failure Therapy

Heart failure is a complex disease characterised 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 10%. The disease is associated with a dyssynchronous contraction pattern of the heart ventricles, which can be treated with CRT.

Source: Biotronik 

11 March 2014