The US Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed to market a new low profile sheath for delivery of its Impella device.
Compared to the existing 14Fr sheath used for placement of Impella CP, the new sheath maintains the same inner diameter, but reduces the outer diameter by nearly 2Fr. 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, Abiomed said in a press release.
The low profile sheath is the first sheath specifically engineered to be compatible with the Impella single-access technique, which removes the need for an additional access site, the press release goes on to add. Additionally, it is designed to simplify access and ease-of-use by eliminating the peel-away sheath and the need for the re-access sheath for patients who are sent to the intensive care unit.
These features are also intended to further minimise vascular complications and bleeding, facilitate easier delivery into the vasculature with a hydrophilic coated long-taper dilator, reducing the need for multiple steps of serial dilation, and enable easier management of the patient during heart pump removal and vascular closure as Impella can be removed directly from the sheath without re-wiring.
“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,” said Chuck Simonton, Abiomed’s chief medical officer. Abiomed will begin a phased roll-out of the Impella low profile sheath this quarter.