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Harvest Technologies Corporation erhält CE-Kennzeichnung für erweiterte klinische Indikation zur Behandlung nicht optionaler kritischer Extremitätenischämie
Date:11/19/2012

PLYMOUTH, Massachusetts, 19. November 2012 /PRNewswire/ -- Harvest Technologies, ein führender Anbieter fortschrittlicher Zelltherapien, freut sich bekanntzugeben, die CE-Kennzeichnung für eine erweiterte klinische Indikation für sein SmartPrep®2-System zur konzentrierten Knochenmarkentnahme (BMAC®2) erhalten zu haben.

The British Standards Institution (BSI), eine benannte Stelle unter der Medizinprodukterichtlinie (Medical Device Directive), hat eine Zertifizierung ausgestellt, die angibt, dass das SmartPrep®2-System zur konzentrierten Knochenmarkentnahme (BMAC®2) als Point-of-Care für die sichere und schnelle Vorbereitung autologen, kernhaltigen Zellkonzentrats aus Knochenmarkentnahmen (Bone Marrow Aspiration - BMA) zur Abgabe in ischämisches Gewebe der von nicht-optionaler kritischer Extremitätenischämie betroffenen Extremität verwendet werden soll.

Zum ersten Mal hat ein Unternehmen für eine autologe Point-of-Care-Zelltherapie ausreichende klinische Nachweise, um die Genehmigung einer benannten Stelle zur Vermarktung eines bestimmten Produkts für diese klinische Verwendung zu erhalten.  

Im Vorfeld der Zertifizierung nahm die BSI umfassende Untersuchungen klinischer Daten aus fast 50 klinischen Studien und Untersuchungen vor, darunter auch Daten, die aus dem BMAC2-System von Harvest Technologies stammen. Frühere Studien haben gezeigt, dass Patienten mit kritischer Extremitätenischämie, die unter Gewebeverlust (Gangräne oder Geschwüre) leiden, ernsthaft dem Risiko einer Amputation ausgesetzt sind. Studien von Harvest haben gezeigt, dass die Verwendung des BMAC2-Systems dieses Risiko reduziert und eine praktikable Option für den Erhalt der Extremitäten darstellt. Die Studien von Harvest konnten außerdem Verbesserungen des Ruheschmerzes bei Patienten mit schweren Ruheschmerzen nachweisen.

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