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FDA approves quadripolar LV leads for CRT
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Boston Scientific announced it has received FDA approval for its quadripolar left ventricular leads for use with cardiac resynchronization therapy devices in patients at risk for sudden cardiac death.
The 3D-shaped quadripolar leads (ACUITY X4) have four electrodes and are designed to facilitate easier placement in the vasculature and to allow pacing at an optimal site to improve patient response to CRT therapy, according to a company press release.
Approval was based on data from NAVIGATE X4, a prospective, nonrandomized, multicenter trial of 764 patients. In that study, all primary safety and efficacy endpoints were met during 6 months of follow-up.
Suneet Mittal
“Data collected in the NAVIGATE X4 study demonstrate that these leads are safe and effective for use with CRT devices,” principal investigator Suneet Mittal, MD, director of the electrophysiology laboratory for Valley Hospital Health System, said in a press release. The trial also demonstrated fast lead implant times, stable placement and improving pacing performance of the leads, he said.
Also in February, Boston Scientific announced that the ACUITY X4 Quadripolar LV leads will be used in the ENABLE MRI study, which is intended to enroll 500 patients at 60 centers worldwide. Boston Scientific will use the findings of this trial to seek FDA approval for updated labeling for MRI-conditional use on ICD and CRT systems, including its Extended Longevity, MINI ICDs and X4 CRT defibrillator systems, including leads, according to the release.
Disclosure: Mittal reports consulting for Boston Scientific, Medtronic, Sorin and St. Jude Medical.