After the United States Food and Drug Administration (USFDA) issued an advisory over Abbott’s fully absorbable stent Absorb, the Indian regulator Central Drug Standards Organisation (CDSCO) has also asked the company to report any adverse effects caused due to the stent.
However, this is not the first time Absorb’s efficacy is being questioned. In 2016, a comparison done between two of Abbott’s latest stents suggested that Absorb was not a superior quality product.
In fact, a three-year trial reflected that Abbott’s Absorb was not superior even to its own Xience Everolimus stent. Reports suggest that late scaffold thrombosis was