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Luna(TM) Aneurysm Embolization System von Nfocus Neuromedical, Inc. erhält CE-Kennzeichnung


News provided by

Nfocus Neuromedical, Inc.

Feb 15, 2011, 07:55 ET

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PALO ALTO, Kalifornien, February 15, 2011 /PRNewswire/ --

- Bedeutender Meilenstein für innovatives Instrument, das zur Behandlung von Hirn-Aneurysmen entworfen wurde -

Nfocus Neuromedical, Inc., ein Anbieter innovativer medizintechnischer Geräte, das sich auf die zukünftige Behandlungsmethode für Hirn-Aneurysmen spezialisiert hat, gab heute den Erhalt der CE-Kennzeichnung für sein Luna(TM) Aneurysm Embolization System (AES) zur Behandlung von Patienten mit Hirn-Aneurysmen bekannt. Das Luna AES wurde für einen einmaligen Einsatz und als einfach zu handhabendes System für die Behandlung von Hirn-Aneurysmen, vor oder nach einem Bruch, entworfen.

"Hirn-Aneurysmen wurden ursprünglich operativ behandelt. Die aktuellere Behandlung besteht aus der Platzierung einer Drahtspirale mithilfe eines Katheters", so Eric Milledge, CEO von Nfocus Neuromedical. "Operationen können traumatisch und kostspielig sein, und die Spiralen Bergen das Risiko, dass das Aneurysma nicht vollständig behandelt wird. Das Luna AES stellt für die Behandlung dieser Patienten einen riesigen Fortschritt dar."

Schätzungen zufolge wird eine von 15 Personen im Laufe ihres Lebens ein Hirn-Aneurysma entwickeln.(1) Der Bruch eines Aneurysmas kann Hirnschläge, Hirnschäden und sogar den Tod zur Folge haben.

Das Luna AES behandelt Hirn-Aneurysmen, indem es den Blutfluss blockiert (embolisiert) und gleichzeitig ein Gerüst liefert, um das Gewebewachstum in einer Aneurysma-Öffnung zu fördern und eine Barriere zu schaffen. Für die Behandlung mit dem Luna wird ein ovales Nitinol-Implantat aus einer Nickel-Titanium-Legierung, eingesetzt. Dieses Implantat erweitert sich selbst und besteht aus mehreren Schichten. Dank seiner Eigenschaften kann das Instrument leicht in einen konventionellen Katheter eingeführt werden und sich danach schnell und einfach beim Einsatz im Aneurysma in voller Grösse öffnen.

"Die CE-Zulassung ist ein wichtiger Meilenstein für Nfocus", so Robert O'Holla, Vice President of Regulatory Affairs bei Nfocus Neuromedical. "Das Luna AES ist unser Vorzeigeprodukt und wir freuen uns auf die Zusammenarbeit mit Ärzten und Krankenhäusern in Europa, um diese wichtige neue Technologie weiterzuentwickeln."

Informationen zu Nfocus Neuromedical, Inc.

Nfocus entwickelt die Behandlungsmethode der Zukunft für Hirn-Aneurysmen. Das innovative LUNA(TM)-Produkt des Unternehmens ist ein einfach zu handhabendes Embolisierungsinstrument, das für einen einmaligen Einsatz bestimmt und ein direkter Ersatz für abtrennbare Spiralen ist. Nfocus wird von drei wichtigen Venturefonds in den USA und OUS unterstützt: DFJ ePlanet Capital, Technology Partners und InCube Ventures. Weitere Investoren sind Raffles Capital und Endeavor Vision. Weitere Informationen erhalten Sie auf http://www.nfocusneuro.com.

(1) - http://www.brainaneurysm.com/

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