Abbott's fully absorbable stent under the lens of Indian regulator

Reports suggest that late scaffold thrombosis was higher in the case of Abbot's Absorb stent

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 higher in the case of Absorb than Xience. While six patients with Absorb had late scaffold thrombosis, none with Xience had such symptoms.

Last week, in Europe, Abbott had stopped commercial use of Absorb as a registry has been initiated. Only those who are part of that registry could use Absorb. The stent will not be available to physicians out of choice. 

The company stated, “The objective of the EU registries is similar to post-approval observational studies and training being conducted in other parts of the world to confirm the effect of current implantation technique on clinical outcomes.”

Abbott India spokesperson said that the current advisory is specific to countries in the EU. The company also stated that Absorb trials from around the world have demonstrated that optimalt implantation technique results in outcomes comparable to the best-in-class metallic drug eluting stent, with the added feature of leaving no metal behind once it dissolves.

Absorb was approved by the USFDA in July last year. The company claimed that it is a novel product as it does not leave behind any residue as other stents do. It was the most expensive stent available in the market at close to Rs 300,000 in the beginning. Subsequently, the price of the product was brought down to a little less than Rs 200,000.

Claiming that Absorb is unique, the company even tried to push for a special price when the Indian government planned to cap the price of stents. Eventually, the National Pharmaceutical Pricing Authority (NPPA) felt that superiority of any stent over the other could be proved. With that, the NPPA fixed the price of all drug eluting stents at Rs 29,600 in February this year.