Reminder on the intended use of Zenith Alpha™ Thoracic Endovascular Graft

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.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.