Medtronic, Inc. (MDT: Quote) announced results from its largest international, prospective, single-arm clinical trial evaluating the Medtronic CoreValve System in patients with severe aortic stenosis who are at high-risk for surgical aortic valve replacement, or SAVR.
The data showed that patients in a real-world setting experienced high procedural success combined with positive clinical outcomes. At present, the CoreValve System is limited to investigational use in the United States.
Called the Medtronic CoreValve ADVANCE Study, survival rates were high at both 30 days and 6 months, rates that are consistent with previously reported data from national registries in Europe. The procedural success rate was 97.8 percent, and overall complication rates were low with stroke rates of 2.9 percent and MACCE (Major Adverse Cardiac & Cerebrovascular Events) rates of 8.3 percent at 30 days. Also, patients in the study experienced significant improvement in valve function.
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by RTT Staff Writer
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