Boston Scientific has received FDA approval for its ACUITY X4 Quadripolar Left Ventricular (LV) leads, which are the wires that connect cardiac resynchronization therapy (CRT) devices to the heart. This is the first time that the company is offering both the device and the leads to the U.S. market.

The LV leads are made up of four electrodes that are positioned in a 3-D shape. They were designed in a way that makes it easier for physicians to place them in the vasculature and also to help them pace from an optimal site to improve the patient’s response to CRT therapy.

The FDA approval was based on data from a prospective, non-randomized, multi-center clinical trial that involved 764 patients, called the NAVIGATE X4 study. After six months, the LV leads were shown to be safe and effective for use with CRT devices.
To try to get FDA approval for MR imaging across Boston Scientific’s implanted cardiac defibrillation (ICD) and CRT systems, the company initiated its global ENABLE MRI study earlier this month. The portfolio of ACUITY X4 Quadripolar LV leads will be included in the study, which will enroll as many as 500 patients at about 60 sites.

The findings of the study will be submitted to the regulatory authorities in the U.S. and Asia. In the U.S. the MR-conditional labeling will include current and future families of Extended Longevity and MINI ICDs and the X4 cardiac resynchronization therapy defibrillator systems, including leads.

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