A first-of-its-kind dissolving medical stent has finally received federal approval for the treatment of clogged arteries among patients in the United States.
Manufactured by Abbott Laboratories, the medical implant known as the Absorb stent dissolves slowly in the body. It was reviewed by the U.S. FDA in March this year and was granted approval on Tuesday, July 5, after months of waiting.
Absorb, which is already sold in Europe and Asia, is touted as the answer to the longstanding problem with conventional stents. Typical stents are permanent, mesh-wire tubes used after a surgical procedure that removes fatty plaque.
It is also the only completely dissolving stent permitted for coronary artery disease treatment. Coronary artery disease affects more than 15 million people in the U.S. and remains the primary cause of mortality around the world.
According to scientists, Absorb disappears completely in three years after it is originally implanted and after it has done its job of keeping a clogged artery open. The stent also promotes the healing of the treated artery segment.
"The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease," says Gregg Stone, chairman of the clinical trial program for the medical stent.
However, some experts say there is a caveat: the Absorb bioresorbable heart stent has not been shown to be safer than traditional metal stents.
In the early 2000s, the use of metallic stents as a treatment for patients who suffered a heart attack and experienced chest pain caused by clogged arteries had surged. These metallic stents are still used by about 850,000 patients in the U.S. every year.
Doctors, however, have scaled back on the use of metallic stents because of safety concerns, evidence that they are overused and insurance cost-cutting.
Past studies have suggested that arteries implanted with metallic stents had higher risks of blood clots, which can potentially result in a heart attack down the road.
Another five-year study revealed that patients who had stent implants for treatment of chest pains fared about as well as patients who received medications.
Amid all these safety concerns, Abbott and other companies started to develop dissolving stents that would melt away slowly like stitches. This could presumably reduce complications.
A company study submitted to the FDA revealed that the results for patients who received Absorb and patients who received metallic stents were quite similar. Heart-related complications were also found to be a bit higher with the dissolving stent — 7.8 for Absorb patients versus 6.1 for metallic stent patients. This was not considered statistically significant.
Meanwhile, Abbott plans to offer Absorb to hospitals in the U.S., beginning with interventional cardiology centers that took part in the Absorb clinical trials.
Photo: Lenore Edman | Flickr
