Abiomed (Nasdaq:ABMD) announced today that it received FDA 510(k) clearance for its Impella low-profile sheath.
Danvers, Massachusetts-based Abiomed designed its sheath to maintain the same inner diameter as the existing 14 French (Fr) sheath used for Impella CP placement. However, the new sheath reduces the outer diameter by nearly 2 Fr.
The sheath’s smaller size, along with other technological advancements, facilitates easier Impella insertion and removal. Abiomed said in a news release that it helps to reduce procedural steps and help improve outcomes.
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