Abiomed: FDA Grants 510(k) Clearance for Impella Low Profile Sheath

 The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement of Impella CP, the new sheath maintains the same inner diameter, but reduces the outer diameter by nearly 2 Fr. As a result of its smaller size and other technological advancements, the Low Profile Sheath will facilitate easier Impella insertion and removal, reduce procedural steps and help improve outcomes.

https://finance.yahoo.com/news/u-fda-grants-510-k-115800158.html