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CE Mark Approval; First Implants

Manufacturing Group | December 20, 2013

Boston Scientific Announces Approval & First Implants of Its Next-Generation X4 Quadripolar CRT-D Systems

Boston Scientific Corp. 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.  

The X4 line of quadripolar CRT-Ds offers the largest number of pacing vector options in the industry and helps physicians effectively address high-pacing capture thresholds and phrenic nerve stimulation, a common complication of CRT therapy due to close proximity of the phrenic nerve to the desired pacing location in the left ventricle. The X4 CRT-Ds also feature Boston Scientific's 6-year warranty and industry-leading longevity. An independent, single-center, observational study of 646 CRT-D recipients (n= 173 BSX, 416 MDT, 57 SJM devices) implanted between Jan. 1, 2008m and Dec. 31, 2010m recently published in the United States showed that during 2.7+/-1.5 years follow-up, only four percent of Boston Scientific device batteries had depleted, compared to seven percent from St. Jude Medical and 25% from Medtronic.[iii] X4 CRT-Ds utilize the same, industry-leading battery capacity and advanced battery chemistry as the Boston Scientific devices used in this study. 

Following CE Mark approval of the X4 quadripolar CRT-D systems, Boston Scientific plans to initiate a global clinical trial to gather additional data on ACUITY X4 leads in patients indicated for a CRT-D. This prospective, non-randomized observational study, Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY X4 (RALLY X4), is expected to enroll up to 1,000 patients who will receive the ACUITY X4 leads at approximately 100 centers across 18 countries.

"Heart failure is a major cardiovascular problem and CRT-Ds can save lives and improve quality of life. The CE Mark approval of our innovative quadripolar CRT-D systems is truly a milestone when it comes to treating patients with heart failure and at risk of sudden cardiac arrest," said Michael Onuscheck, senior vice president and president, Boston Scientific Europe. "We are also excited to provide physicians with a CRT-D system that can significantly improve the implant experience."

Boston Scientific's X4 quadripolar CRT-D system is currently approved for use in CE Mark countries only. In the US, the X4 quadripolar CRT-D system is an investigational device and not available for sale. 

Source: Boston Scientific Corp.

[i] American Heart Association:; content was last reviewed on 08/20/2012.

[ii] ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death Europace 2006; 8:746-837.

[iii] Mian Bilal Alam, Muhammad Bilal Munir, Rohit Rattan, Susan Flanigan, Evan Adelstein, Sandeep Jain, and Samir Saba, Battery longevity in cardiac resynchronization therapy implantable cardioverter defibrillators, Europace 2013 : eut301v1-eut301.

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