A NEW absorbable heart stent is being recalled by Australian health authorities amid heart attack fears.
The Therapeutic Goods Administration (TGA) is recalling the Absorb Bioresorbable Vascular Scaffold system - an implanted medical device use to open blocked coronary arteries - after research showed it was linked to elevated rates of heart attacks and blood clots.
The stent, which is used in more than 100 countries including the US, is fully absorbed by the body over time.
The manufacturer, Abbott Vascular Australia, is recalling all unused stock of the device and the TGA has removed it from the Australian Register of Therapeutic Goods (ARTG).
The TGA said the decision to undertake the recall and remove Absorb BVS System from the ARTG "was based on data from recent analysis that showed an elevated rate of major adverse cardiac events, specifically heart attack and blood clot, when compared to patients treated with an another alternate stent".
It advised anyone with an Absorb BVS System, or anyone who cares for someone with one, to talk to their doctor to ensure they're receiving appropriate treatment and to know the signs and symptoms of heart attack and blood clot.
"If you experience any cardiac-related symptoms, such as irregular heartbeats, chest pain, or shortness of breath, seek immediate medical attention," the TGA said.
Patients should continue taking medicines, such as dual antiplatelet therapy (DAPT), to reduce the risks of heart attack and blood clot.
An Abbott spokesperson confirmed the company is "limiting use of the Absorb dissolving stent in Australia to select hospitals in a clinical trial setting to monitor implantation technique".
" A very small percentage of patients undergoing coronary angioplasty (the opening of blocked heart arteries) each year in Australia receive Absorb. Abbott has informed all physicians who use Absorb in Australia of the restriction," the spokesperson said.
"Patients should speak with their physician if they have any concerns."