Abbott consigue la AUTORIZACIÓN europea para primer stent absorbible

por Brendon Nafziger, DOTmed News Associate Editor | January 10, 2011
Abbott said Monday it received European approval to market what it says is the world's first absorbable drug-eluting stent.

The stent, which props open clogged blood vessels, is made of polylactide, the same substance in absorbable sutures. It dissolves into the artery after about two years, the company said.

Abbott said because the stent dissolves, it could restore vessel function and reduce the need for blood-thinning drugs. Early studies suggested no blood clots appeared in patients up to four years after implantation.

European approval was based on data from the Absorb Clinical Trials, a prospective, non-randomized trial that enrolled 131 patients in eight countries. Abbott said it will launch a follow-up, randomized study in Europe this year, with around 500 patients at 40 centers. It will also run the Absorb Extend trial at up to 100 centers in North America, South America, Europe and Asia, with around 1,000 patients with more complex coronary artery disease.

The Abbott Park, Ill.-based company said with CE Mark approval, the device, dubbed Absorb, will become available in select European sites by the end of the year and then more widely launched in 2012. Future U.S. availability is unknown.