Abbott Laboratories’ said its experimental dissolvable heart stent has received approval in Europe, a key milestone in the development of the next-generation heart device for patients in the U.S. and around the world.
The North Chicago-based drug and medical device giant said it is the first-ever government regulatory approval of an absorbable stent.
Abbott hopes the drug-coated stent, which is inserted after balloon angioplasty to keep blocked pathways open, evolves into the next generation of medical devices for clearing clogged arteries.
Unlike existing stents made of a metal mesh or drug-coated metal, Abbott’s drug-coated “bioabsorbable” stent is designed to be absorbed and slowly metabolized by the coronary artery. After two years, Abbott said patients will no longer need a metal stent in their arteries, according to clinical trials.
Cardiology experts say the absorbable stent holds promise but it remains unclear whether it would eventually replace existing stents on the market, which have been hailed for their effectiveness at keeping arteries to the heart open and reducing the need for heart surgeries. These experts say Abbott’s absorbable stent needs more study in the U.S. where trials have yet to begin.
“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 work works an advisory to Abbott’s cardiology program. “You no longer have that foreign body in the artery. You treat it and after a couple of years it is gone.”
Stents are lucrative for their makers. The average price of the drug coated variety runs between $1,500 to $2,000 per stent. The company would not disclose the potential sales price of the absorbable stent.
Abbott’s coronary stent sales including its drug-coated metal stent Xience jumped 38 percent to $1.6 billion in 2009, the most recent full-year financial information is available compared to 2008. Abbott’s 2010 earnings and revenue figures will be released Jan. 26.
Abbott said a “a full-scale European commercial launch” is planned by the end of 2012. Abbott said U.S. trials have yet to begin, but 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.
“(The) technology has the potential to revolutionize the treatment of coronary artery disease – with the prospect for positive therapeutic outcomes resulting from its unique ability to treat a blocked vessel, potentially restore natural vessel function and disappear within approximately two years after implant,” said Abbott senior vice president of its vascular division, Robert Hance.