A device that was likely thought to be just science fiction is turning into, well, actual science.
Some 225 hospitals across the country are taking part in a large-scale trial of absorbable stents designed for heart surgery that will begin to dissolve into the body six months after an angioplasty.
Experts say the stent, made of poly¬lactic acid, has made large strides in recent years and is gaining momentum in other countries.
“A lot of companies are doing it because it really holds a lot of promise,” said Len Czuba, of Czuba Enterprises Inc., a Chicago-based product design and development firm that specializes in plastics engineering for medical devices.
The stents are designed to remain in place for six months and then begin to be absorbed into the body's normal metabolic systems. In three years, the stent will be completely gone.
Czuba said the stents don't have to be made for just heart conditions, but work for any long-term implants that were once made out of metals, ceramics or durable plastics. The device will simply go away and the patient no longer has to worry about a foreign object being in their body, which could be rejected, cause infection or more clots.
Abbott Vascular is currently conducting a trial of its Absorb bioresorbable vascular scaffold with approximately 2,250 patients across the country, and some internationally.
“We obviously see tremendous upside to a device that leaves the body and doesn't leave anything permanently in the artery,” said Steve Kelly, public affairs director for Abbott Vascular, a division of Abbott Laboratories.
Kelly said preliminary results of the trial are encouraging.
“We're looking at it for other parts of the body,” he said about the absorbable material. “Obviously, the coronary application is what we're focused on right now, and we definitely are looking at using it in other applications.”
While accepted and used in Europe, the Middle East and parts of Asia, it is not yet approved for use in the United States, and Kelly said the company plans to submit it for approval from the Food and Drug Administration in 2015.
Dr. Amr Abbas, medical director of interventional cardiology research for Royal Oak, Mich.-based Beaumont Health System, said the polylactide material will simply end up becoming water and carbon dioxide in the patient's body. He said the advancement is likely to become the fourth evolution in interventional cardiology.
“Sometimes [traditional] stents can block up and we have to put in other stents, and those block up,” Abbas said. “The possibility of putting in a stent, and then having to put in another stent as if you are doing it for the first time is really remarkable.”
It's still early, and it's difficult to determine how big the market could ultimately be, Abbas said, but the market likely won't be limited to angioplasty.
“The potential to extend this to other areas of the body is also there, which is also very exciting,” he said.
Czuba said he believes the process could have far-reaching implications, possibly far beyond the borders of the U.S. “As companies make this product more routinely available and doctors around the world see how it's useful, we'll be able to treat people in other parts of the world that don't have the sophisticated, trained cardiovascular surgeons that we have here,” Czuba said.
Parts of the world where stenting is rare can become more commonplace, he said. “It's going to have a huge, huge impact.”
