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.
  • Price Action: ABMD shares are up 2.76% at $256.16 on the last check Monday.
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