India Issues Alert On Abbott’s Absorb But Xience Is Mainstay

India has issued an alert on Abbott’s Absorb bioresorbable coronary stent, in the backdrop of certain safety signals flagged up in global clinical studies pertaining to the product. The Indian order advises patients and physicians to report adverse events “suspected to be associated” with the use of the product.

India’s Central Drugs Standard Control Organization (CDSCO) has put out an alert on Abbott Laboratories Inc.'s bioresorbable drug-eluting coronary stent, Absorb GT1 BVS, in the backdrop of global concerns of over-elevated rates of major adverse cardiac events associated with the product.

“Based on the three years’ clinical data analysis from ABSORB II, it has been observed that there is an over-elevated...

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