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In Brief: St. Jude

This article was originally published in The Gray Sheet

Executive Summary

St. Jude: Pacesetter subsidiary gains FDA approval of a PMA supplement for its Passive Plus TiN pacemaker lead. The TiN lead features an electrode tip coated with titanium nitride, which St. Jude says "has been shown to increase the microscopic surface area of the electrode tip and to reduce polarization." St. Jude also announces receipt of an investigational device exemption for its Passive Plus DX lead and export approval to sell its AV Plus lead in Sweden. The Passive Plus DX has a "steroid-eluding electrode" in addition to titanium nitride coating. The steroid-eluding AV Plus lead, in clinicals in the U.S. and Europe, is indicated exclusively for use with Pacesetter's AddVent VDDR pulse generator; the product "enables AddVent to sense the atrium and ventricle and to pace the ventricle appropriately using a single lead," St. Jude says...
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