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Health Sciences Authority
Dear Healthcare Professional Letters

Update to the Instruction For Use (IFU) of Endologix Nellix® EndoVascular Aneurysm Sealing System due to potential risks of implant displacement, endoleaks, and/or aneurysm enlargement

Audiences

Healthcare professional

Product type

Medical devices

16 November 2016

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Somnotec (S) Pte Ltd and DKSH Singapore Pte Ltd have issued Dear Healthcare Professional Letters to notify healthcare professionals of an update to the Instruction For Use (IFU) of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System). Endologix’s surveillance programmes have detected higher than anticipated rates of implant displacement, endoleaks, and/or aneurysm enlargement. As such, Endologix is updating the IFU with more detailed information regarding indications for use, patient selection criteria and procedural best practices, to reduce these potential clinical risks. Healthcare professionals are advised to consider the updated instructions when using the Nellix System for their patients.


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.

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