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CryoLife kündigt erste Implantation des HeRO Transplantats in Europa an
Date:7/31/2013

bei Professor Fourneau und Professor Heye, dass sie die Operation durchführten. Während des Rests des Jahres werden wir weitere Ärzte auf diese Operation vorbereiten, um damit die erweiterte Markteinführung in Europa ab Anfang 2014 zu unterstützen. Wir glauben unvermindert, dass das HeRO Transplantat eine nennenswerte Chance bei der Bereitstellung einer verbesserten Option des Dialysezugangs für Patienten mit Niereninsuffizienz im Endstadium bietet und, dass es ein Wachstumstreiber des Unternehmens sein wird."

Über das HeRO TransplantatDas HeRO Transplantat erhielt die erste FDA 510(k) Zulassung im Jahr 2008 und die erste CE-Kennzeichnung im Jahr 2011. Es ist für katheterabhängige ESRD-Patienten mit langfristiger Hämodialyse indiziert, die alle anderen Zugangsmöglichkeiten, wie AV-Fisteln und -Transplantate ausgenutzt haben (AVF und AVT). Vor der Einführung des HeRO Transplantats war für diese Patienten der Zugang über perkutan getunnelte Dialysekatheter (TDCs) die einzige Möglichkeit, die allerdings teurer ist, höhere Infektionsraten aufweist, den Lebensstil des Patienten einschränkt und zu Venenstenose oder Verengung der zentralen Venen führen kann. Das HeRO Transplantat vermeidet die Beschränkungen der TDCs, indem es ein vollständiges, subkutanes Transplantat bereitstellt, das wie ein normales Zugangstransplantat während der Dialyse funktioniert und im Vergleich zu TDCs verbesserten Blutfluss, sowie eine um 69 Prozent reduzierte Bakteriämie (Bakterien im Blut) bietet. Das HeRO Transplantat ist die einzige subkutane AV-Zugangslösung, die einen klinisch nachgewiesenen Langzeitzugang für Hämodialysepatienten mit Stenose in den zentralen Venen bietet.

Das HeRO Transplantat wurde bisher bereits bei mehr als 6.000 Patienten eingesetzt und wird durch fast 130 veröffentlichte klinische Studien und Präsentationen unterm
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SOURCE CryoLife, Inc.
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