Abbott Company logo for business and Dan Miller. Company logos.
Updated: February 10, 2013 5:56PM
ABBOTT PARK — Abbott Laboratories announced Tuesday the start of clinical trials in the U.S. for the next generation of its drug-eluting stent for the treatment of coronary artery disease.
The Absorb III random, controlled trial is designed to enroll approximately 2,250 patients and compare the performance of Abbott’s Absorb bioresorbable vascular scaffold device to the company’s Xience family of drug-eluting stents.
The start of this trial in the United States follows the of Absorb was recently recent commercially launched in Europe and parts of Latin America and Asia, including India.
Coronary artery disease is a narrowing of one or more arteries that supply blood to the heart. Absorb, made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures, works by opening a clogged vessel and restoring blood flow to the heart similar to a drug-eluting metallic stent, the current standard of care, the company said.
Absorb then dissolves into the blood vessel, leaving behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic implant, Abbott officials said.
“The Absorb III trial will provide important insight about the benefits of Absorb in U.S. patients with heart disease and will supplement the knowledge gained about this technology since the start of international clinical trials of Absorb in 2006,” said Dr. Charles Simonton, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “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.”