Reminder on the intended use of Zenith Alpha™ Thoracic Endovascular Graft
Healthcare professional
Medical devices
18 September 2018
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Cook South East Asia Pte. Ltd. would like to remind healthcare professionals of the intended use of Zenith Alpha™ Thoracic Endovascular Graft as it has been used off-label for thoracic aortic dissections. The Instructions For Use (IFU) states that the safety and effectiveness of the Zenith Alpha™ Thoracic Endovascular Graft and ancillary components have not been evaluated in the patient populations for dissection. Healthcare professionals are advised to use the Zenith Alpha™ Thoracic Endovascular Graft and ancillary components as specified in the IFU. No device needs to be returned and patients already treated for a dissection should receive standard follow up procedures. Please refer to the letter for details.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.
