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[UPDATED] Absorbable heart device recalled due to patient heart attacks


A new absorbable heart device has been recalled by manufacturer Abbott Vascular Australia, after research linked it to increased rates of heart attacks and blood clots.

The Absorb Bioresorbable Vascular Scaffold system is a fully absorbable implanted stent which is used to open blocked coronary arteries.

It is in the process of being removed from the Australian Register of Therapeutic Goods (ARTG), and manufacturer Abbott Vascular is recalling all unused stock.

However, use of the device will continue in select Australian hospitals in a clinical trial setting to monitor implantation technique.

The decision to recall the product and remove it from the Register was based on data that showed an elevated rate of major adverse cardiac events, particularly heart attacks and blood clots, when compared to patients who used an alternate stent, according to the TGA.

“Data from Absorb trials around the world demonstrate that when current implantation technique is used, efficacy and safety results are comparable to the gold-standard metallic drug eluting Xience stent, with the added feature of leaving no metal behind once it dissolves,” said a spokesperson from Abbott Vascular.

The spokesperson also noted that the overall rate of stent thrombosis (blood clot) in Australia since Absorb was introduced in 2013 is less than 0.8 per cent; and 0.2 per cent since the introduction of the current implantation technique in 2015.

“These are comparable stent thrombosis rates for metallic drug eluting stents, which are typically from <1 per cent in the first year to 0.5 per cent in the subsequent years.”

A small percentage of patients undergoing coronary angioplasty (the opening of blocked heart arteries) each year in Australia receive Absorb.

The TGA has advised any patients with the stent to seek urgent medical attention if they experience new cardiac symptoms such as irregular heartbeat, chest pain or shortness of breath.

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