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CSA Medical präsentiert frühe klinische Daten zum Cryospray-Dosiersystem RejuvenAir auf dem Kongress der European Respiratory Society (ERS)
  • USA - Français
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News provided by

CSA Medical, Inc.

Sep 11, 2017, 11:56 ET

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MAILAND, 11. September 2017 /PRNewswire/ -- CSA Medical veranstaltete ein Mini-Symposium auf dem Kongress der European Respiratory Society (ERS) am Sonntag, den 10. September 2017 in Mailand, Italien. Bei diesem Symposium wurden die 3-Monats-Nachbeobachtungsdaten aus der Machbarkeitsstudie des Unternehmens zum Einsatz des Cryospray-Dosiersystems RejuvenAir® vorgestellt, das sich derzeit in der Entwicklung für die Behandlung chronischer Bronchitis befindet.

Bis heute wurden dreißig Patienten mit chronischer Bronchitis in die Sicherheits- und Machbarkeitsstudie (NCT02483637) aufgenommen. Zwanzig dieser Patienten haben ihre Behandlung abgeschlossen und davon haben zwölf Patienten die 3-Monats-Nachbeobachtung abgeschlossen. Die Behandlung wurde ohne jegliche intraoperativen negativen Ereignisse durchgeführt. 

Die Ergebnisse der 3-Monats-Nachbeobachtung von zwölf Patienten zeigten eine positive Wirkung auf die Patienten mit einer durchschnittlichen Verbesserung der Werte des SGRQ-Fragebogens (Saint George Respiratory Questionnaire) von 6,1 Punkten und einer durchschnittlichen Verbesserung der Werte des COPD-Bewertungstests (COPD Assessment Test/CAT) von 3,2 Punkten. Eine SGRQ-Verbesserung von 4 Punkten und eine CAT-Verbesserung von 2 Punkten wird laut von Fachkollegen überprüfter Literatur als klinisch bedeutsam angesehen. Im Anschluss an die Präsentation der klinischen Daten bemerkte Professor Dr. med. Pallav Shah, Fellow des Royal College of Physicians von Royal Brompton: „Ein gesteuertes Gefrieren der Atemwege mit dem RejuvenAir System erscheint sicher und verbessert die Symptome der Patienten mit chronischer Bronchitis."

Chronische Bronchitis ist eine Untergruppe der chronisch obstruktiven Lungenkrankheit (Chronic Obstructive Pulmonary Disease/COPD). Die Diagnose einer chronischen Bronchitis definiert sich durch Husten mit erhöhtem Sputum über eine Dauer von drei Monaten während zwei aufeinanderfolgender Jahre. Neben einer chronischen Entzündung, Husten und der vermehrten Schleimproduktion können bei der chronischen Bronchitis eine Atemwegsobstruktion/teilweise blockierte Atemwege aufgrund der Schwellung und übermäßigen Schleimerzeugung in den Bronchien oder Kurzatmigkeit (Dyspnoe) auftreten.

Über CSA Medical

CSA Medical, Inc. entwickelt und produziert eine proprietäre interventionelle Spray-Kryotherapie-Technologieplattform. Diese nutzt Spezialkatheter zur Freisetzung von flüssigem Stickstoff-Spray im Körper, um unerwünschtes Gewebe einzufrieren und zu zerstören und so ein regenerierendes Heilungsmuster zu ermöglichen. CSA produziert und vertreibt diese Technologie in den USA als das truFreeze-System, um unerwünschtes gutartiges und bösartiges Gewebe abzutragen. Das RejuvenAir System befindet sich derzeit in der klinischen Untersuchung und ist nicht im Handel erhältlich.

Um mehr über unsere Technologie zu erfahren, besuchen Sie bitte www.csamedical.com.

Weitere Informationen erhalten Sie bei:  
Amy Sarli, CSA Medical
+1-781-538-4779 / [email protected]

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