Abbott Ready To Initiate ABSORB Clinical Trials In U.S., China, And Japan
Abbott announced that it has completed patient enrollment for three ABSORB clinical trials in the U.S., China, and Japan. The trials will support approvals of Abbott’s Absorb Bioresorbable Vascular Scaffold (BVS) for patients with blocked heart vessels in the three countries.
The ABSORB III clinical trial enrolled an estimated 2,000 patients in the U.S. and will evaluate ABSORB in people with coronary artery disease. The trial’s primary endpoint is target lesion free of ABSORB compared to the XIENCE family of drug eluting stents at one year. ABSORB Japan and ABSORB China enrolled about 400 patients each, and will evaluate TLF and late loss at one year in comparison to XIENCE.
“The randomized clinical trials for Absorb demonstrate Abbott's commitment to provide the highest level of clinical evidence possible to assess Absorb compared to metallic drug eluting stents – the current standard of care. We look forward to evaluating the results of these trials, which we intend to submit to support regulatory approvals of the device,” said Charles A. Simonton, divisional VP of Medical Affairs and CMO of Abbott Vascular.
ABSORB is made of naturally dissolving material polylactide commonly used in medical implants such as dissolving sutures. The device opens a blocked vessel and restores blood flow to the heart similar to a metallic stent. However, ABSORB dissolves over time and leaves a potentially more flexible vessel free from a permanent metallic stent.
“The medical community eagerly awaits the results of the randomized trials for Absorb. We have made tremendous progress in interventional cardiology with the advances in metallic stents. A device that could provide similar benefits but not leave behind a permanent implant has the potential to transform the way coronary artery disease is treated,” said Dean Kereiakes, medical director of The Christ Hospital Heart & Vascular Center and the Lindner Research Center in Cincinnati.
The U.S., Japan, and China combined markets represent over 50 percent of the world’s heart stent market. Abbott has secured the CE mark for ABSORB in 2011 and the device is available in over 60 countries.