First 4F MR Conditional CRT Lead CE Marked and In Use

Frequent visitor to our pages, cardiovascular device company Biotronik has announced the first implantations of the Sentus ProMRI® lead.

Background

Heart failure is associated with a dyssynchronous contraction pattern of the heart ventricles, which can be treated with Cardiac Resynchronisation Therapy(CRT) using any number of commercially available implantable systems. 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. In fact there is an estimated 50 to 75 percent probability that patients will be indicated for an MRI over the lifetime of their device.

For this reason, Biotronik became a pioneer in what it calls “MR conditional” leads, in other words implantable CRT systems that are not adversely affected by MRI scans. Notably other manufacturers also now offer MR conditional lead systems.

That said, Biotronik’s Sentus ProMRI bipolar CRT lead is the first MR conditional lead with a 4F diameter—approximately 1.6 millimeters. An ultra-thin lead, it enables access to particularly challenging vessels and offers expanded pacing options. The new CRT lead received CE mark approval in early February and has now been implanted at a number of centres in Europe. The new lead can be coupled with the company’s Biotronik Home Monitoring system, which offers a continuous monitoring solution that keeps patients out of hospital while offering the reassurance that their condition is under remote surveillance

Physician comments

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.”

Source: Biotronik SE & Co, KG.

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