Biotronik’s ultra-tiny MRI-safe CRT lead obtains CE Mark clearance

6 March 2014 (Last Updated March 6th, 2014 01:00)

Manufacturer of technology specialising in heart failure therapy, Biotronik, has announced the European approval and the first implantations of its bipolar cardiac resynchronisation therapy lead Sentus ProMRI.

biotronik

Manufacturer of technology specialising in heart failure therapy, Biotronik, has announced the European approval and the first implantations of its bipolar cardiac resynchronisation therapy lead Sentus ProMRI.

The company's bipolar cardiac resynchronisation therapy (CRT) lead 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, Sentus lead allows cardiac failure patients with a CRT implant to safely undergo MRI (magnetic resonance imaging) scans.

The new CRT lead received CE Mark approval in early February.

Bordeaux University Hospital France Dr Philippe Ritter said: "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."

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

"Heart failure patients require complex disease management."

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

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

German Heart Centre Munich Germany Dr Christof Kolb said: "This is particularly important for heart failure patients, as their status can change quickly and often."

The new lead coupled with the company's Biotronik home monitoring system 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 rehospitalisation.

According to GlobalData estimates, the CRT market in Europe was valued at $1.18bn in 2012 and is expected to grow at a CAGR of 9.1% to reach $2.18bn by 2019.


Image: Biotronik wins a CE mark for an ultra-tiny, MRI-safe CRT lead. Photo: courtesy of Biotronik.