04
March
2014
|
00:00
Europe/Amsterdam

CE Approval of the First 4F MR Conditional Lead

Cardiologists Philippe Ritter and Christof Kolb Implant the New BIOTRONIK Sentus ProMRI® Bipolar Lead in Heart Failure Patients

BERLIN, Germany, March 4, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology that specializes in heart failure therapy, announced the first implantations of the Sentus ProMRI® lead today. BIOTRONIK’s bipolar cardiac resynchronization therapy (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. 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 percent 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.”

  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.

About BIOTRONIK:

BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.