Consumers and health professionals are advised that the TGA has recently reviewed the 2 year data from clinical studies on the Absorb BVS. This data demonstrates an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic XIENCE drug-eluting stent also manufactured by Abbott Vascular.
The BVS is implanted via angioplasty and functions to open blocked coronary arteries. It is fully absorbed by the body over time. The BVS was approved by the TGA in September 2013 (ARTG ID 214148).
These major adverse cardiac events included cardiac death, heart attack, need for an additional procedure to re-open the treated heart vessel, and were more likely when the device was placed in small coronary vessels.
The TGA is continuing to analyse these outcomes and to monitor the performance of the BVS in ongoing clinical studies and adverse event reporting.
Information for consumers
Patients that have been treated with a BVS should continue to take any anti-platelet medications prescribed by their health care providers.
If you (or someone you care for) have been treated with a BVS and you (or they) are experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath, you should seek clinical care.
Information for health professionals
Health care providers are advised to:
Use caution when selecting this device, in particular follow instructions for patient and target vessel selection, included in the BVS physician labeling.
Advise patients experiencing any new cardiac symptoms to seek clinical care.
Advise BVS patients to follow the recommendations for DAPT prescribed by their health care providers.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.