FDA Approves First Dissolving Stent for US Patients
A slowly dissolving medical implant for treating clogged arteries has won approval from the Food and Drug Administration.
The agency approved the Absorb stent Tuesday for patients with coronary artery disease, which causes the buildup of fatty plaque in the arteries and causes about 370,000 U.S. deaths each year. The new stent is designed to dissolve over three years.
Older stents are permanent, mesh-wire tubes that hold open arteries after a procedure to clear plaque.
Each year, those are implanted in about 850,000 U.S. patients who have suffered a heart attack or experienced chest pain. Their safety has been questioned after some studies suggested stented arteries faced a higher risk of blood clots.
However, the new stent hasn’t been shown yet to reduce risk of clots and heart complications.
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