05.29.14
Biotronik SE & Co. KG has announced the European approval and the first implantations of its bipolar cardiac resynchronization therapy lead Sentus ProMRI.
The new cathode ray tube (CRT) lead, which received CE mark approval in early February, is claimed to be the first magnetic resonance conditional lead with a 4F diameter --- approximately 1.6 millimeter.
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, heart failure patients often are in poor general health, 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 percent to 75 percent probability that patients will be indicated for an MRI over the lifetime of their device.
With Biotronik's 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.
Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.
The new cathode ray tube (CRT) lead, which received CE mark approval in early February, is claimed to be the first magnetic resonance conditional lead with a 4F diameter --- approximately 1.6 millimeter.
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, heart failure patients often are in poor general health, 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 percent to 75 percent probability that patients will be indicated for an MRI over the lifetime of their device.
With Biotronik's 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.
Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.