This article was originally published in The Gray Sheet
Executive SummaryGem II VR (Model 7229) single-chamber implantable cardioverter defibrillator is released in the U.S. and internationally following FDA approval July 27 of a premarket approval application supplement, the company reports July 29. The 39 cc, 77 gram device offers full-energy (30 Joules) and high-energy (35 Joules) options for ventricular rate responsive pacing therapy and is 20% smaller than its predecessor, the 48 cc Gem ICD. Competitors include Guidant (39 cc Mini IV single-chamber ICD/pacer), St. Jude (single-chamber, 34 cc Profile MD ICD), and Angeion (47 cc single-chamber Lyra 2020 ICD)
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