In Brief: Angeion AngePass 4040
This article was originally published in The Gray Sheet
Executive Summary
Angeion AngePass 4040: Synthelabo subsidiary Ela plans to commence European sales of the 7.5 French single-pass lead in early 1998 after regulatory approval is granted for Angeion's and Ela's proposed 50-50 joint venture ("The Gray Sheet" Oct. 6, In Brief). Angeion reports Nov. 24 that it gained a CE Mark for the 4040 model series. Available in three lengths, the 4040 series "offers a tined passive fixation tip and is placed in the apex of the right ventricle," the firm says. The lead is designed for use with Angeion's Small Cap and Tuned biphastic waveform features, which are incorporated in the firm's Sentinel implantable cardioverter defibrillator and the 2020 ICD series, for which a premarket approval application and an investigational device exemption are pending at FDA, respectively...
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