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ExAblate erhält erweiterte CE-Kennzeichnung zur Behandlung gutartiger und bösartiger Knochentumore


News provided by

InSightec Ltd

Jul 01, 2013, 08:18 ET

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TIRAT CARMEL, Israel, July 1, 2013 /PRNewswire/ --

-- Zu den Indikationen zählt die Behandlung von Knochenmetastasen, multiplen Myelomen, Osteoidosteomen, Facettengelenken und sonstigen Knochentumoren --

InSightec Ltd, das führende Unternehmen im Bereich der MRT-gesteureten fokussierten Ultraschalltherapie, gab heute bekannt, dass dessen ExAblate®-Systeme die erweiterte europäische CE-Kennzeichnung zur lokalen Behandlung gutartiger und bösartiger primärer und sekundärer Knochentumore erhalten haben. Hierzu zählen unter anderem multiple Myelome, Knochenmetastasen, Osteoidosteome sowie Rückenschmerzen im Bereich der Facettengelenke. Die CE-Kennzeichnung gilt für ExAblate 2000 und 2100 sowie für das ExAblate 2100 Conformal Bone System. Die CE-Kennzeichnung beruhte auf zusätzlich publizierten klinischen Nachweisen.


ExAblate vereint therapeutische, akustische Ultraschallwellen mit kontinuierlicher Behandlungskontrolle durch MRT. Ärzte nutzen MRT-Bilder zur Planung der Therapie, zur entsprechenden Beratung und zur Kontrolle der Behandlungsergebnisse. Fokussierte Ultraschallenergie könnte zur Ablation des Tumors oder zur Zerstörung jener Nerven eingesetzt werden, die den Schmerz verursachen bzw. weiterleiten, was eine rasche Schmerzreduktion zur Folge hätte. Im Jahr 2007 erhielt ExAblate 2000 die CE-Kennzeichnung zur Schmerzlinderung bei schmerzhaften Knochenmetastasen. Im Jahr 2012 folgte dann die FDA-Zulassung von ExAblate 2000 und 2100 für die gleiche Indikation.


"Die erweiterte CE-Kennzeichnung, die nun auch das Conformal Bone System sowie neue Indikationen wie Osteoidosteome, die Denervierung von Facettengelenken und die Ablation sonstiger Knochentumore umfasst, ist ein weiterer bedeutender Meilenstein im Rahmen unseres Vorhabens, diese innovative, nichtinvasive Therapie zusätzlichen Patientengruppen zur Verfügung zu stellen", so Dr. Kobi Vortman, der Gründer und CEO von InSightec. "Die klinischen Ergebnisse waren sehr vielversprechend und haben gezeigt, dass fokussierter Ultraschall sowohl zur Schmerzlinderung des Patienten als auch zur Ablation von Tumoren eingesetzt werden kann, was Patienten eine erhöhte Lebensqualität bietet."

Informationen zu InSightec

InSightec Ltd. ist ein Privatunternehmen von Elbit Imaging, General Electric und MediTech Advisors. InSightec wurde 1999 mit dem Ziel gegründet, die MRgFUS-Technologie (MRT-gesteuerter fokussierter Ultraschall) mithilfe von ExAblate zu einer klinisch brauchbaren Technologie weiterzuentwickeln. Aufgrund von Innovation und des potenziellen Nutzens für die Menschheit hat ExAblate bereits zahlreiche Auszeichnungen erhalten, darunter die Technology Innovation Awards von The Wall Street Journal und den IST Grand Prize der Europäischen Union. Das Magazin TIME bezeichnete fokussierten Ultraschall kürzlich als "eine der 50 besten Erfindungen". Klicken Sie hier, um Näheres zur Unternehmensvision von InSightec zu erfahren. Nähere Informationen zu Behandlungszentren erhalten Sie hier: http://www.insightec.com.

Pressekontakt:

Lynn Golumbic
+972-4-8131380
[email protected]

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