Update to the Instructions for Use for Absorb™ and Absorb GT1™ Bioresorbable Vascular Scaffold Systems

Abbott Laboratories (S) Pte Ltd would like to inform healthcare professionals of an update to the procedure techniques in the Instructions for Use (IFU) for all sizes of Absorb™ and Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) Systems. This is based on recently published results of ABSORB III, a clinical trial that compared the safety and effectiveness of Absorb BVS to the XIENCE, a metallic drug eluting stent.  Analysis of the clinical data and other published data identified that a change to the procedure technique will facilitate optimal clinical outcomes and reduce the likelihood of thrombosis. Healthcare professionals are reminded to follow the IFU instructions and the key changes outlined in the letter. 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 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.