The TGA has moved to restrict use of a controversial cardiac stent in Australia amid growing fears worldwide that the device is linked to elevated rates of heart attack and thrombosis.
Issuing a safety alert yesterday, the drug and medical devices watchdog said its decision to remove the Absorb BVS System (Abbott Vascular) from the ARTG was based on recent data that showed an elevated rate of major adverse cardiac events, specifically heart attack and blood clot, when compared to patients treated with another stent.
The Absorb BVS System will now be only be available in Australia through clinical trials and the unapproved product pathways schemes, the regulator said.
The Australian recall comes just weeks after an urgent field safety notice issued to cardiologists in Europe and detailing the company’s concerns about the device was leaked on twitter.
The letter, written by Abbott, said it was withdrawing the stent from widespread use in Europe effective May 31, 2017 restricting its availability to select sites participating in a clinical registry. It also said no further BVS stents will be provided to non-registry sites after March 31, 2017.
“These sites are instructed to cease implants and existing inventory will be removed,” the letter stated.
In that letter the pharmaceutical company said it was awaiting further data to answer questions about optimal DAPT duration after implantation and to confirm whether improved implantation techniques would mitigate the higher event rates.
It’s been a bad year for the contentious stent as a flood of concerns about safety began to pour in from around the world.