FDA Approves Dissolving Stents For Heart Patients [Video]

The Food and Drug Administration (FDA) approved a dissolving stent for heart patients in the United States. According to a press release from Abbott Labs, the FDA “has approved the company’s Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States.” Coronary artery disease impacts over 15 million people in the United States alone, and is one of the world’s leading causes of death.

A stent is a small mesh tube, usually made of metal, used to treat narrow or weak arteries. Stents are placed in arteries as part of a procedure called coronary angioplasty or percutaneous coronary intervention (PCI) to restore blood through blocked arteries. Stents may also be placed in narrow arteries or weak arteries to improve blood flow. Stents support the inner wall of the artery and prevent arteries from bursting. Until now, stents were usually made of metal mesh, or sometimes fabric (stent grafts) in larger arteries. Abbott’s Absorb stents are made of a naturally dissolving plastic.

Gregg W. Stone, M.D., FACC, FSCAI, director of cardiovascular research and education at the Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital and the chairman of the Absorb clinical trial program, praised the dissolving stents.

“The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease. This novel technology appeals to both physicians and patients alike because after treating the underlying blockage it is completely absorbed, leaving nothing behind. 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.”

San Francisco Gate explained that Abbott’s Absorb is already in use in more than 100 countries, but it was only approved by the FDA for use in the U.S. on July 5. Abbott’s Absorb dissolving stents offer an alternative to traditional stents. Almost 1 million Americans have stents implanted each year to clear clogged arteries, creating a $1.4 billion market in the U.S. alone. Abbott Laboratories controls more than a third of the U.S. stent market.

Traditional stents remain permanently inside the body. They can increase the risk of blood clots. The dissolving stents are designed to hold arteries open for three years, then dissolve into the body, like dissolving sutures. News-Medical.Net explained that “Absorb is made of polyactic acid similar to material used in dissolving sutures.” The dissolving stent is metabolized after two to three years through the process of hydrolysis.

Dr. Hiram Bezarra, Medical Director, Cardiovascular Imaging Core Laboratory – UH Harrington Heart & Vascular Institute, compared the dissolving stents to drug-eluting stents (DES), which release drugs slowly over time to prevent blood clots or the artery becoming blocked again.

“Absorb is a new, potentially game-changing therapy for coronary artery disease. While it may never totally replace traditional DES, this novel technology gives us the ability to repair a patient’s artery with comparable healing and safety and reduces long-term complications.”

Reuters said that the dissolving stents “allow the blood vessel to return to a natural state.” This is especially beneficial to heart patients who might need multiple surgeries over the years.

Doug Tyler and Phyllis Camp were among the first Americans to have dissolving stents inserted in their arteries.

If you or a loved one needed an angioplasty, would you prefer a permanent metal stent or a dissolving stent?

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[Photo via Abbott Laboratories]