Boston Scientific receives CE Mark for X4 CRT-D systems

Boston Scientific has received European CE Mark approval for its X4 line of quadripolar cardiac resynchronisation therapy defibrillator (CRT-D) systems.

This new approval covers the Autogen X4, Dynagen X4, and Inogen X4 CRT-D devices, as well as a suite of Acuity X4 quadripolar LV leads and the Acuity Pro lead delivery system. They are designed for use in the treatment of heart failure and sudden cardiac arrest.

They offer the largest number of pacing vector options in the industry, helping physicians to effectively address high-pacing capture thresholds and phrenic nerve stimulation.

Following CE Mark approval of the X4 systems, the first implants of the devices are now taking place. Boston Scientific plans to initiate a global clinical trial to gather additional data on Acuity X4 leads in patients indicated for a CRT-D.

Michael Onuscheck, senior vice-president and president for Boston Scientific in Europe, said: "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."

This comes after the company received EU approval for its Direxion Torqueable Microcatheter in the EU and US last month.