CHICAGO—Abbott Laboratories said Monday that its experimental dissolvable heart stent was approved for use in Europe, a milestone in the development of the next-generation heart device for patients around the world.
The North Chicago-based drug and medical-device giant said it is the first government regulatory approval of a “bioabsorbable” stent. Abbott hopes the drug-coated absorbable stent, which is inserted after balloon angioplasty to keep blocked pathways open, evolves into an advancement of medical devices for clearing clogged arteries.
Unlike stents made of a metal mesh or drug-coated metal, Abbott’s stent is designed to be absorbed and slowly metabolized by the coronary arteries.
Cardiology experts say the absorbable stent holds promise, but it remains unclear whether it eventually would replace stents now on the market, which have been praised for their effectiveness at keeping arteries to the heart open and reducing the need for heart surgeries. They say Abbott’s absorbable stent needs more study in the U.S., where trials have yet to begin and doctors are largely unfamiliar with it.
“The sex appeal of this is that you use (an absorbable stent), and after a couple of years it is gone,” said Dr. Charles Davidson, an interventional cardiologist at Northwestern Memorial Hospital, who has worked as an adviser to Abbott’s cardiology device development.
Stents are lucrative for their makers. The drug-coated variety costs $1,500 to $2,000. Abbott would not disclose the potential sales price of an absorbable stent, but a spokesman said the company expects it to be “priced at a premium to current drug (coated) stents . . . given the benefits the device represents.”
Abbott’s coronary stent sales, including its drug-coated metal stent Xience, generated $1.6 billion in 2009, according to the most recent full-year financial information available, 38 percent more than in 2008.
Abbott said a full-scale European commercial launch is planned by the end of 2012. The company plans to begin a global trial, including study of patients in the U.S., before the end of this year. That means the absorbable stent would not be submitted to the U.S. Food and Drug Administration for possible approval until 2015.
In earlier trials, the device effectively treated heart disease and absorbed into the walls of patients’ arteries, with no clots reported after three years.
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(c) 2011, Chicago Tribune.
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