Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for the ACUITY™ X4 Quadripolar Left Ventricular (LV) leads. The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the leads – to the U.S. market.
The family of ACUITY X4 Quadripolar LV leads is engineered with four electrodes along a unique 3D shape. The leads are designed to enable physicians to place them in the vasculature easily and to allow pacing at an optimal site to improve the patient response to CRT therapy.
FDA approval of the ACUITY X4 Quadripolar LV leads was based on data from the NAVIGATE X4 study, a prospective, non-randomized, multicenter clinical trial that enrolled 764 patients. The study successfully met the primary safety and efficacy endpoints through six months of follow up.
Earlier this month, the company initiated the global ENABLE MRI study, which is intended to support FDA approval for magnetic resonance imaging (MRI) across the company's currently approved implanted cardiac defibrillation (ICD) and CRT systems. The newly approved family of ACUITY X4 Quadripolar LV leads will be used in this study, which is expected to enroll as many as 500 patients at approximately 60 sites worldwide. Trial findings will be submitted to regulatory authorities in Asia and the U.S. when the company requests updated labeling for MRI-conditional use on ICD and CRT systems, including those that have previously been implanted.
