Die US-amerikanische Aufsichtsbehörde FDA hat der expandierbaren perkutanen Impella ECP Herzpumpe von Abiomed (NASDAQ: ABMD) den Status als "Breakthrough Device" ("bahnbrechendes Gerät") erteilt. Damit
Hyderabad hospital has saved the life of a 45-year-old man by performing a non surgical pump technology. Impella is the safest and most effective heart pump for critical individuals and is the only US FDA-approved non-surgical heart pump technology.
Abiomed Europe GmbH: MEDCERT Enables the Use of the Single Access Procedure with Impella CP Introducer Sheaths in Europe
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Following consultation with its notified body, MEDCERT GmbH, Abiomed is introducing the single access procedure with Impella CP introducer sheaths for the treatment of heart disease in Europe.
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 enables the treating physician not only to place Impella heart pumps in the ventricle via the 14 French Impella CP introducer sheaths, but also to insert other catheters and introducer sheaths. Thus, cardiac interventions such as percutaneous coronary interventions can also be performed via the 14 French Impella CP introducer sheaths.
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