Medical technology firm Abiomed has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Impella Low Profile Sheath.
The sheath with modern technological features will cut down procedural steps and enable smooth Impella insertion and removal, resulting in enhanced outcomes.
While the Low Profile Sheath has the same inner diameter as the 14 French (Fr) sheath used for Impella CP placement, it features a reduced outer diameter by around 2Fr.
