Health care giant Abbott Labs has begun the ABSORB-III clinical trial of its drug-eluting bioresorbable stent, Absorb.
Absorb is the evolution of the modern stent in that it is made of completely dissolvable material, allowing it to absorb back into the bloodstream once its job is done.
The trial comes after Absorb's commercial release in Europe. Results from the ABSORB-III trial will be used in Abbott's filing for FDA approval for U.S. sales of the next-generation stent.
The ABSORB-III's primary endpoint involves testing lesion failure for safety and efficacy of the stent. Some patients will also be monitored for secondary endpoints, such as vasomotion -- how much a blood vessel regains natural motion after the dissolution of the Absorb stent.
Abbott Vascular's chief medical officer and division vice president of Medical Affairs spoke of the trial in a company press release, saying, "The advancement of Absorb into clinical trials in the United States represents an important step in the process of filing for U.S. regulatory approval -- with the goal of establishing Absorb as a new therapeutic option to treat U.S. patients with heart disease, the number one killer of men and women."
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