Boston Scientific landed FDA’s approval for its ACUITY X4 Quadripolar Left Ventricular Leads for use with the firm’s cardiac resynchronization therapy devices (CRTs). The four electrodes on the Leads allow cardiologists to choose from a greater variety of pacing options over only having two electrodes to work with.
The company is **w working toward getting the Leads Approved for use under MRI. A clinical study has started toward that goal, which will hopefully allow patients with these life-saving implants to also be able to take advantage of life-saving magnetic resonance scans as needed.
FDA approval of the ACUITY X4 Quadripolar LV Leads was based on data from the NAVIGATE X4 study, a prospective, **n-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.
02-24-2016, 11:03 PM
Boston Sci’s ACUITY X4 Quadripolar Left Ventricular Leads Approved in U.S.
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