Women and men benefited similarly from the CoreValve System even though women (51 percent of patients) and men (49 percent of patients) had different risk profiles. Specifically, at the time of enrollment, women as compared to men were:
- Older than males (82.2 years vs. 79.9 years; p-value <0.001);
- Had higher average gradients (47.6 vs. 43.5 mmHg; p-value <0.001) and peak gradients (79.0 vs. 72.5 mmHg; p-value <0.001), a measure of blood flow across the valve;
- Had less coronary artery disease (46 percent vs. 70 percent; p-value <0.001); and
- Were prescribed fewer cardiovascular medications, including cholesterol-lowering medications (p-value 0.002) and statins (p-value 0.013).
The Medtronic CoreValve System received CE (Conformite Europeenne) Mark in 2007 for the treatment of patients deemed at high or extreme risk for surgery. Since then, it has been implanted in more than 27,000 people in more than 50 countries outside the U.S. The CoreValve System is available in three sizes (26mm, 29mm and 31mm), and is the only transcatheter aortic valve implantation system approved for direct aortic or subclavian access.Worldwide, approximately 300,000 people have been diagnosed with symptomatic, severe aortic stenosis, and approximately one-third of these patients are deemed at too high a risk for open-heart surgery.1 About MedtronicMedtronic, Inc. ( www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 1 Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Bernard Iung et al. Eur Heart J (December 2005) 26(24): 2714-2720.