First-ever dissolving heart stent gets FDA review
WASHINGTON (AP) — A disappearing medical implant gets a closer look from the Food and Drug Administration this week.
The FDA meets Tuesday to review Abbott Laboratories' first-of-a-kind heart stent that dissolves into the body after helping to clear fat-clogged arteries.
Abbott has asked the agency to approve its Absorb stent as an alternative to permanent, metal implants that have long been used to treat narrowing arteries that can lead to heart attack and death.
But FDA regulators have questions about the safety and effectiveness of the experimental device. In a review posted late last week, FDA scientists noted that rates of heart-related complications were actually slightly higher with Absorb than with older stents, according to a company study.
The agency will ask a panel of outside experts to discuss Abbott's data.