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January 28, 2014
09:08 EDTJNJCordis announces 'positive' two-year data from INCRAFT trial
Cordis, a unit of Johnson & Johnson, announced the presentation of two-year data from its INNOVATION Trial. Data from the study continues to demonstrate that the INCRAFT System performs well in patients suffering from abdominal aortic aneurysms two years after treatment. The company said, "These positive results are encouraging and build on the favorable short and mid-term outcomes of the INCRAFT System observed in the recently published one-year results of the INNOVATION Trial. Cordis’ INCRAFT System has the potential to be a valuable alternative to current devices on the market. The system is designed to offer increased applicability in the broad spectrum of anatomical sizes encountered in patients undergoing endovascular aneurysm repair.” The INCRAFT System is approved for investigational device use only and it not for sale anywhere in the world. The device is currently being investigated in a global pivotal clinical study in the U.S. and Japan called the INSPIRATION Trial, which completed enrollment in August 2013. One-year follow-up data from the trial will support a Premarket Approval application to the U.S. Food and Drug Administration and a Shonin application in Japan.
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