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Medical Devices / Submissions and Approvals / Research and Development

Abbott Completes Enrollment in U.S., China, Japan Absorb Trials

April 15, 2014

Enrollment is complete in U.S., Chinese and Japanese trials of Abbott’s everolimus-eluting Absorb bioresorbable vascular scaffold, the Illinois drugmaker said. The studies will compare the effectiveness of Absorb versus Abbott’s drug-eluting Xience stents in opening blocked heart vessels.

The trials involve a total of 2,800 coronary artery disease patients: 2,000 in the U.S. and 400 each in China and Japan. Patients in the U.S. arm will be followed for target lesion failure at one year, while the Chinese and Japanese studies will look at TLF and late loss at one year.

Results from the trials will be used to support regulatory filings in the three jurisdictions. Abbott spokeswoman Gayathri Badrinath said the company expects to file in the U.S. and Japan in 2015, with China following sometime thereafter.

The scaffold is currently marketed in Europe, the Middle East, Latin America and India.
Absorb is made from polylactide, which is commonly used in dissolvable stitches. — Lena Freund

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