Boston Scientific (NYSE:BSX) said it won a nod from European regulators for its next-generation line of quadripolar cardiac resynchronization therapy defibrillators, the X4 CRT-Ds.

The CE Mark approval covers Natick, Mass.-based Boston Scientific’s 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, according to a press release.

The medtech maker also said it’s planning a 1,000-patient global clinical trial of the Acuity X4 leads called the Rally X4 study in patients indicated for a CRT-D device.

"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," Boston Scientific Europe president Michael Onuscheck said in prepared remarks. "We are also excited to provide physicians with a CRT-D system that can significantly improve the implant experience."

"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," added Dr. Antonio Curnis, head of electrophysiolog at Brescia University’s Civili Hospital in Italy, 1 of the 1st doctors to implant the newly approved devices. "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."

BSX shares were trading at $11.36 apiece today as of about 10:40 a.m., down 0.4%.