Updates in IFU following clinical findings of thrombus and graft occlusion with Zenith Alpha™ Thoracic Endovascular Graft

Cook South East Asia Pte Ltd would like to inform healthcare professionals of an update to the Instructions for Use (IFU) for Zenith Alpha™ Thoracic Endovascular Graft due to new information that include recommendations on patient selection, device planning and sizing, and patient monitoring for blunt thoracic aortic injury (BTAI). This update is due to clinical findings and reports on graft thrombosis/occlusion during global commercial use of the device, each following treatment for BTAI. No devices need to be returned, and patients already treated for BTAI should be followed up according to the current IFU. Healthcare professionals are advised to 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.