U.S. FDA Grants 510(k) Clearance for Impella Low Profile Sheath

Tuesday, October 18, 2022

The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed 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.

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. 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.
• Further minimize 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.
• Facilitate easier management of the patient during heart pump removal and vascular closure because 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, MD, Abiomed’s chief medical officer.

Abiomed will begin a phased roll-out of the Impella Low Profile Sheath this quarter.