In Brief: Angeion
This article was originally published in The Gray Sheet
Executive Summary
Angeion: Company gains investigational device exemption for clinical studies of its Model 2020 and 2022 implantable cardioverter defibrillators at 35 centers in the U.S. and plans to commence U.S. trials "in a few weeks," company Chairman and CEO Whitney McFarlin reports at a Feb. 5 session of the Piper Jaffray medical device conference in New York City. The 2020, with a weight of 89 grams and volume of 47 cc, is 25% smaller than the firm's 110 gram, 60 cc Sentinel series ICD, for which a June 1997 premarket approval application is pending at FDA ("The Gray Sheet" June 23, In Brief). The 2020 family and Sentinel feature small cap, Tuned biphasic waveform and the ASEC II dual battery system. The 2020 family also offers 60 minutes of electrogram storage. The 2022 model is specifically intended as a replacement device compatible with other manufacturers' lead systems. The devices will be marketed in the U.S. through Angellan Medical Systems' 100-person direct sales force. Angellan is a 50/50 joint venture established by Angeion and Synthelabo's Ela Medical unit. McFarlin also tells investors that Angeion is developing a model 2030 single chamber ICD and a 2100 dual-chamber ICD, for which clinical trials will begin in 1998 and 1999, respectively...