U.S. FDA Grants 510(k) Clearance for Impella Low Profile Sheath
Smaller Sheath Simplifies Access and Improves Ease-of-Use

Abiomed’s 14 Fr Impella Low Profile Sheath, in its assembled state (Photo: Business Wire)
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
ABOUT IMPELLA HEART PUMPS
Impella CP with SmartAssist® is
Impella CP with SmartAssist® and Impella 5.5® with SmartAssist® are
ABOUT
Based in
FORWARD-LOOKING STATEMENTS
Any forward-looking statements are subject to risks and uncertainties such as those described in
View source version on businesswire.com: https://www.businesswire.com/news/home/20221017005313/en/
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