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Boston Scientific Announces CE Mark Approval And First Implants Of Its Next-Generation X4 Quadripolar CRT-D Systems

NATICK, Mass., Dec. 17, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval of its X4 line of quadripolar CRT-D systems, including the AUTOGEN™ X4, DYNAGEN™ X4, and INOGEN™ X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY™ X4 quadripolar LV leads and the ACUITY™ PRO lead delivery system.  The company's latest devices to treat heart failure and sudden cardiac arrest are designed to advance patient care and improve the implant experience. 

Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body's needs for blood and oxygen.[i] Sudden cardiac arrest (SCA) is a sudden, unexpected death caused by loss of heart function. SCA is a leading cause of death in Europe, claiming more than 350,000 lives per year.[ii]  

One of the first implants of the AUTOGEN X4 CRT-Ds was performed by Prof. Antonio Curnis, head of Electrophysiology, Brescia University, Civili Hospital, Brescia, Italy, and Dr. Luca Bontempi, an electrophysiologist in the same unit.

"The unique design of the ACUITY X4 lead allows me to pace from more optimal locations while enabling excellent stability of the lead, low battery consumption and avoiding phrenic nerve stimulation, which are all important issues for CRT patients," said Prof. Curnis. "Thanks to the 17 pacing vector options, it is possible to manage micro dislodgments of the lead and optimize pacing threshold without additional procedures, drastically reducing the risk to patients.  This, along with Boston Scientific's outstanding battery technology, delivers a CRT-D system that truly benefits patients over the long term."  

The ACUITY X4 suite of quadripolar LV leads are designed with multiple electrode spacing configurations to accommodate individual patient anatomy, including 3D spiral designs to maximize electrode contact with the myocardium and minimize pacing capture thresholds in non-apical locations. These leads also feature multiple fixation options to optimize stability and the industry's smallest lead tip to enable physicians to access vessels unavailable to other quadripolar leads.  

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