CE Mark and First Implants of Boston Scientific’s X4 Quadripolar CRT-D Systems

Boston Scientific

Boston Scientific Corporation has received CE Mark approval of its X4 line of quadripolar cardiac resynchronization therapy defibrillator (CRT-D) systems, designed to advance patient care and improve the implant experience in the treatment of heart failure and sudden cardiac arrest.

Background

Boston Scientific’s X4 line includes the AUTOGEN™ X4, DYNAGEN™ X4, and INOGEN™ X4  CRT-Ds, a suite of ACUITY™ X4 quadripolar LV leads and the ACUITY™ PRO lead delivery system.

The ACUITY X4 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.

Boston Scientific says its 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 the company’s 6-year warranty and industry-leading longevity.

Boston Scientific also points to an independent, single-center, observational study showing that its battery life outperforms that of its main rivals.

The company now plans to initiate a global clinical trial to gather additional data on ACUITY X4 leads in patients indicated for a CRT-D.

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.

Physician comments

“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.”

Company comments

“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.”

Source: Boston Scientific Corporation, PR Newswire

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