Next-generation X4 quadripolar CRT-D systems are CE-marked


Boston Scientific has announced it has received CE mark approval of its X4 line of quadripolar CRT-D systems including Autogen X4, Dynagen X4, and Inogen X4 cardiac resynchronisation therapy defibrillators (CRT-Ds), a suite of Acuity X4 quadripolar left ventricular (LV) leads and the Acuity Pro lead delivery system. These devices are designed to treat heart failure and sudden cardiac arrest.

One of the first implants of the Autogen X4 CRT-Ds was performed by Antonio Curnis, head of Electrophysiology, Brescia University, Civili Hospital, Brescia, Italy, and 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 Curnis. “Thanks to the 17 pacing vector options, it is possible to manage micro dislodgments of the lead and optimise 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 maximise electrode contact with the myocardium and minimise pacing capture thresholds in non-apical locations. These leads also feature multiple fixation options to optimise stability and, according to the company, the industry’s smallest lead tip to enable physicians to access vessels unavailable to other quadripolar leads.

Following CE mark approval of the X4 quadripolar CRT-D systems, the company announced it has 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-randomised observational RALLY X4 (Maximising CRT delivery by using multipolar coronary sinus lead family Acuity X4) study, is expected to enrol up to 1,000 patients who will receive the Acuity X4 leads at approximately 100 centres across 18 countries.

Boston Scientific’s X4 quadripolar CRT-D system is investigational in the USA, not available for sale in the USA.