FDA Approves Abiomed's Impella Low Profile Sheath

The FDA has granted 510(k) clearance to Abiomed Inc's ABMD Impella Low Profile Sheath.
Compared to the existing 14 French (Fr) sheath used for the placement of Impella CP, the new sheath maintains the same inner diameter but reduces the outer diameter by nearly 2 Fr.
Due to its smaller size and other technological advancements, the Low Profile Sheath facilitates easier Impella insertion and removal, reduces procedural steps, and helps 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.
It simplifies access and ease of use by eliminating the peel-away sheath and the need for the re-access sheath for intensive care unit patients.
Further, minimize vascular complications and bleeding.
Facilitates easier delivery into the vasculature with a hydrophilic-coated long-taper dilator, reducing the need for multiple steps of serial dilation.
Facilitate easier patient management during heart pump removal and vascular closure because Impella can be removed directly from the sheath without re-wiring.
Abiomed will begin a phased roll-out of the Impella Low Profile Sheath this quarter.
The FDA approved Impella CP with SmartAssist for certain advanced heart failure patients.
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