COVID-19: FDA COVID-19 ACİL TEDAVİSİNDE CYTOSORB TEDAVİSİNİ ONAYLADI

Haber

CytoSorb tedavisi, aşırı seviyelerde inflamatuar aracıların etkili bir şekilde azaltabilen ekstrakorporeal kan TEMİZLEME prosedürüne dayanır. Bu TEDAVİ VÜCUT DIŞINDA , sistemik hiperinflamasyon veya septik şokla ilişkili aşırı sistemik inflamatuar yanıtı (“sitokin fırtınası”) hafifletmeyi amaçlamaktadır. Böylece, bir sitokin fırtınasının hayatı tehdit eden komplikasyonlarından kaçınılabilir ve her şeyden önce hemodinamiğin stabilizasyonu desteklenebilir.

DETAYLI BİLGİ VE TAM PROSPEKTÜS: https://www.fda.gov/media/136866/download

*FDA has authorized the emergency use of CytoSorb 300 mL device:
CytoSorb 300mL device is manufactured under and ISO 13485 and CE Mark approved INTRODUCTION 1.1. Intended Use The CytoSorb Device (CytoSorb) is a non-pyrogenic, sterile, single-use device containing adsorbent polymer beads designed to remove cytokines, as blood passes through the device.
CytoSorb is placed in a blood pump circuit. 1
1.2. Indications CytoSorb is indicated for use in conditions where elevated levels of cytokines are present. Maximum Treatment Time per Device: 24 hours.
Adminstration of Therapy:
Day 1: Change device every 12 hours;
Day 2: Change device at 24 hours; Day
3: Change device at 24 hours.
Clinical assessment to be made after 72 hours of use to determine if patient is receiving clinical benefit for for continuation of therapy. (see Section 11: Addendum to IFU for further guidance).
Maximum Blood Flow Rate: 700 mL/min Minimum Blood Flow Rate: 100 mL/min Recommended Blood Flow Rate: 150-500 mL/min Flow rates below 150 mL/min may be required due to limitations of the catheter access, caution should be used at low flow rates as the potential for clotting may increase.