FDA Approves Boston Scientific’s Acuity X4 Leads

FDA has approved Boston Scientific’s 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 company says. The leads are engineered with four electrodes along a “unique 3D shape,” it says, adding that they 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.”

Approval was based on data from the NAVIGATE X4 study, a prospective, non-randomized, multicenter clinical trial that enrolled 764 patients. The study met the primary safety and efficacy endpoints through six months of follow up, Boston Scientific says.