The US Food and Drug Administration has granted approval to Boston Scientific for its Acuity X4 quadripolar left ventricular (LV) leads. With the approval of the leads, the company can now offer its first full X4 cardiac resynchronisation (CRT) system to the US market.
The LV leads comprise four electrodes along a 3D shape. According to a company release, 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.
According to Boston Scientific, the FDA approval of the ACUITY X4 Quadripolar LV leads was based on data from the NAVIGATE X4 study, a prospective, non-randomised, multicentre clinical trial which enrolled 764 patients. The study successfully met the primary safety and efficacy endpoints through six months of follow up.
“Data collected in the NAVIGATE X4 study demonstrate that these leads are safe and effective for use with CRT devices,” says Suneet Mittal, principal investigator and director of the Electrophysiology Laboratory for Valley Hospital Health System, Ridgewood, USA. “The approval is a testament to the strength of the data in this trial, which also demonstrated fast lead implant times, stable lead placement, and improved pacing performance resulting from the unique design of the ACUITY X4 leads.”
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 enrol around 500 patients at approximately 60 sites worldwide. Trial findings will be submitted to regulatory authorities in Asia and the USA when the company requests updated labelling for MRI-conditional use on ICD and CRT systems, including those that have previously been implanted.
The MRI-conditional labelling in the USA would include current and future families of Extended Longevity (EL) and MINI ICDs and the X4 cardiac resynchronisation therapy defibrillator (CRT-D) systems, including leads. In August of 2015, the company received CE mark on MRI conditional labelling on its EL and MINI ICDs and X4 CRT-D systems, as well as the ACUITY X4 quadripolar LV leads, INGEVITY and FINELINE II pacing leads and RELIANCE 4-SITE and 4-FRONT defibrillator leads. The X4 line of CRT-Ds includes the DYNAGEN X4 and INOGEN X4 in the USA.