FDA Approves First-of-its-Kind Dissolving Heart Stent
Abbott announced that the Food and Drug Administration (FDA) has approved Absorb bioresorbable heart stent, the first fully dissolving heart stent available to treat patients with coronary artery disease.
Absorb, a first-of-its-kind medical device, is made of naturally dissolving material similar to sutures. The Absorb stent disappears completely in approximately 3 years after it keeps the clogged artery open and promotes healing of the treated artery segment. Traditional stents that are made of metal are permanent and restrict vessel motion in the treated patient. Gregg W. Stone, MD, FACC, FSCAI, Columbia University Medical Center, explained, "No metal means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities. No metal may also reduce the potential of future blockages that occur with permanent metallic stents, and allows easier access to other treatment options should they prove necessary in the patient's future.”
Clinical studies demonstrated the Absorb bioresorbable stent had comparable short- and mid-term outcomes to Abbott's Xience drug-eluting stent, the leading metallic stent. In the ABSORB III randomized trial (n=2,000), patients who received the Absorb stent experienced comparable rates of specific adverse events in the intended patient population (eg, heart disease-related death, heart attacks, target lesion failure) vs. patients who received the Xience stent at one year.
The Absorb device will be made available to hospitals in the United States, beginning with interventional cardiology centers that participated in Absorb clinical trials. It is sold commercially as the Absorb GT1 Bioresorbable Vascular Scaffold (BVS).
For more information visit Abbott.com.