This article was originally published in The Gray Sheet
CE mark is received for the Model 2020 implantable cardiac defibrillator series, the firm announces June 16. Ela Medical is distributing the ICDs in Europe, where they will be sold under the trade name Lyra. Measuring 46 cc and weighing 87 grams, the 2020 is 25% smaller than the firm's 60 cc, 110 gram Sentinel ICD series. The Model 2020 family also includes the Model 2021 three-port header device and Model 2022, a replacement device which can be used with a variety of leads. U.S. clinical trials for the 2020 series at 35 centers are ongoing ("The Gray Sheet" Feb. 9, In Brief)
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