Boston Scientific Gets European Nod For Next-Gen X4 Quadripolar CRT-D Systems

(RTTNews) - Boston Scientific Corp. (BSX) Tuesday received 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), a suite of ACUITY X4 quadripolar LV leads and the ACUITY PRO lead delivery system.

The company said the latest devices are to treat heart failure and sudden cardiac arrest are designed to advance patient care and improve the implant experience.

Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body's needs for blood and oxygen. Sudden cardiac arrest (SCA) is a sudden, unexpected death caused by loss of heart function. SCA is a leading cause of death in Europe, claiming more than 350,000 lives per year.

Following CE Mark approval of the X4 quadripolar CRT-D systems, Boston Scientific 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-randomized observational study, Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY X4 (RALLY X4), is expected to enroll up to 1,000 patients who will receive the ACUITY X4 leads at approximately 100 centers across 18 countries.

Boston Scientific's X4 quadripolar CRT-D system is currently approved for use in CE Mark countries only. In the US, the X4 quadripolar CRT-D system is an investigational device and not available for sale.