Abbott Labs is seeking FDA approval to sell a novel coronary stent that dissolves after it is implanted, but government scientists have raised questions about potential heart attack and blood clots risks.
The stent, called Absorb, is an alternative to metal stents currently used to prop open arteries cleared of blockages. The stent disappears within three years of the procedure.
An FDA advisory panel meets on Tuesday to consider whether to recommend approval of Absorb. The panel will question data showing more heart attack and stent-related blood clots compared with Abbott’s drug-coated metal Xience stent, as well as address risks associated with the device when used in smaller arteries.
Read the Reuters article