Boston Scientific, a global medical technology company that employs thousands of Minnesotans, on Tuesday announced 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)  -- as well as its ACUITY X4 quadripolar LV leads and the ACUITY PRO lead delivery system. Leads are the wires that connect defibrillators and pacemakers to the heart.

The ACUITY X4 leads are designed with multiple electrodes that help doctors accommodate differences in patient anatomy. With multiple electrodes, the device can deliver therapy even if there is scar tissue that could block an electrical signal. The leads also feature multiple options for attaching the lead to the heart, as well as what Boston Scientific said is the industry's smallest lead tip to enable doctors to access blood vessels unavailable to other quadripolar leads. 

One of the first implants was performed by Prof. Antonio Curnis, head of Electrophysiology, Brescia University, Civili Hospital, Brescia, Italy, and Dr. Luca Bontempi, an electrophysiologist.

"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'soutstanding battery technology, delivers a CRT-D system that truly benefits patients over the long term." 

Following CE Mark approval of the X4 quadripolar CRT-D systems, Boston Scientific plans to start a global clinical trial to gather additional data. The device is not yet available for sale in the United States.

"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."

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