The FDA issued an early alert related to a catheter introducer kit issue from Johnson & Johnson’s Abiomed Heart Recovery unit ...
At Abiomed's European headquarters in Aachen, Germany, Impella heart pumps have been developed and produced for more than 20 years to stabilize and recover the human heart. The single access procedure ...
DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the ...
The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 heart pump. It inserts at 10 French (Fr) and the flexible, ...
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 ...
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The US Food and Drug Administration has granted 510(k) clearance for Abiomed's Impella Low Profile Sheath used to place and manage Impella heart pumps. "The Low Profile Sheath is the first sheath ...
AACHEN, Germany--(BUSINESS WIRE)--Following consultation with its notified body, MEDCERT GmbH, Abiomed is introducing the single access procedure with Impella CP introducer sheaths for the treatment ...
DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (NASDAQ: ABMD) announces the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP heart pump has ...