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.
The new sheath is the first of its type to be compatible with the Impella single-access technique, which helps eliminate the need for another access site.
The latest clearance will enable Abiomed to commence a phased roll-out of the new sheath this quarter.
Abiomed chief medical officer Chuck Simonton said: “Abiomed’s Low Profile Sheath is a game-changing technological achievement that will further improve patient outcomes by making it even easier for physicians to insert, manage and remove Impella heart pumps.”
Impella Low Profile Sheath will ensure ease of use by replacing the peel-away sheath. It will also eliminate the need for a re-access sheath for patients in the intensive care unit.
The sheath equipped with a hydrophilic-coated long-taper dilator ensures easier delivery into the vasculature. This, in turn, decreases the procedures involved in serial dilation.
Further, Impella can be removed directly from the sheath sans re-wiring, thus easing the process of heart pump removal and vascular closure.
The new solution will also help in reducing bleeding, among other vascular complications.
In September, the FDA granted two approvals related to the clinical research of Abiomed’s Impella heart pumps.