An arterial stent that can dissolve after it's done its job has passed a major test, performing as well as conventional stents in a one-year trial, its manufacturer says.
Stents are tiny mesh tubes meant to keep blood vessels open and unclogged after angioplasty, a procedure to open narrowed or obstructed arteries.
Around 850,000 heart disease patients in the U.S. are given stents each year.
Current stents in use in the United States are permanent metal implants, coated with a substance that slowly releases medicine, but they can cause inflammation and present other long-term risks.
The dissolving Absorb stent by Abbot Vascular, already available in Europe, is constructed of a degradable material designed to remain intact for one year, also releasing medicine, then break down and disappear in the following two years.
The material the stent is made from is similar to that used to created dissolving sutures.
"It holds the artery open long enough for the artery to heal," then completely disappears, says Dr. Dean Kereiakes of Christ Heart and Vascular Center in Cincinnati, one of the study leaders. "It can return the artery to its normal, natural structure and function."
Around 2,000 patients in the trial who were fitted with the stent in procedures conducted at 193 sites will be followed for at least five years.
"The trial met all its major endpoints, and given all the attributes my opinion is that it should be approvable," said global study chairman Dr. Gregg Stone.
The study was part of Abbot's aim of securing U.S. Food and Drug Administration approval for offering Absorb in the United States.
Already in use in more than 100 countries around the globe, the Absorb stent has been used to treat more than 125,000 patients, Abbot said in a release.
Doctors will need to learn how to implant the stent, which is slightly larger and softer than metal stents now in use, Stone says.
It will offer another option for doctors and heart patients to consider, he says.
"A lot of patients would much rather have a dissolving stent that returns arteries back to their normal condition," he says. "It will be very good for young patients who will live 30 or 40 years with this decision."
