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![\"CoreValve](\"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/..\/Images\/corevalve-implanted_medtronic.jpg\")
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Last week, Medtronic, the manufacturer of the CoreValve, announced the following:<\/p>\n
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- Enrollment of the CoreValve United States Pivotal Trial is complete. In total, 1,500 patients who are at “high” or “extreme” risk for surgery will participate in the trial.<\/li>\n
- Medtronic received FDA conditional approval to start evaluating CoreValve performance in the “intermediate” risk patient population. Enrollment for this study, known as the SURTAVI trial, will begin shortly.<\/li>\n<\/ul>\n
Reflecting on this announcement, Doctor Adams, MD<\/a>, Chairman of the Department of Cardiothoracic Surgery at Mount Sinai Medical Center, stated:<\/p>\n
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![\"Doctor](\"https:\/\/www.heart-valve-surgery.com\/Images\/david-adams-surgeon.jpg\" "\\"Click")
<\/a>Dr. David Adams<\/p>\n<\/p>\n
“With a sizeable population of Americans with severe aortic stenosis<\/a> who have varying degrees of risk for open-heart aortic valve replacement surgery<\/a>, the CoreValve U.S. Pivotal Trial and SURTAVI Trial are landmark trials that will provide critical insights about the appropriate use of the self-expanding CoreValve System.”<\/p><\/blockquote>\n
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The results of these studies should be very interesting considering that the majority of CoreValve patients have been too frail (or inoperable) for traditional open heart surgery. Since 2007, the CoreValve device has been implanted in more than 30,000 patients in 60 countries.<\/p>\n