Boston Scientific's Acuity X4 quadripolar LV leads are intended to be used with the company's X4 CRT-D systems. This technology is designed to allow better therapy and fewer lead revisions with 17 pacing vector options, according to the company website.
The quad leads received CE Mark in December 2013 as part of the family of X4 quadripolar CRT-D systems. Management anticipates the Acuity quad leads will receive FDA approval in the first half of 2016. The company's full X4 quad system is expected to launch in the first half of 2016 and should help fill gaps in the U.S. product portfolio, according to a Seeking Alpha transcript of management commentary on the third quarter 2015 earnings call.
These products do not have U.S. FDA regulatory clearance or approval as of January 22, 2016.
[Image courtesy of BOSTON SCIENTIFIC CORP.]
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