Medtronic (MDT) Reports Positive Clinical Outcomes for CoreValve System Using Direct Aortic Approach
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Medtronic, Inc. (NYSE: MDT) issued a statement on the results of two studies evaluating the use of the Medtronic CoreValve System delivered through the direct aortic implantation approach. Data presented at the Society of Thoracic Surgeons (STS) 48th Annual Meeting demonstrate positive outcomes when the CoreValve System is implanted using the direct aortic approach, which received CE (Conformité Européenne) Mark in November 2011. The direct aortic approach is also being evaluated in the Medtronic CoreValve U.S. Pivotal Trial.
Data presented during a late-breaking session showed procedural success in 92 of 93 patients treated at 12 centers across Europe. There were no procedural deaths, the overall 30-day mortality rate was 9.7 percent, and with experience (after three cases) the 30-day mortality rate was 7.0 percent. Approximately half of the patients received the replacement valve through a minithoracotomy (an opening between two ribs) and half through a ministernotomy (an opening through the sternum); both minimally-invasive procedures are performed without stopping the heart or penetrating the heart's ventricular wall. Most patients (83.9 percent) had been previously diagnosed with peripheral vascular disease and almost one-third had undergone previous coronary artery bypass surgery (the mean logistic EuroSCORE was 28.0 ± 15.7 indicating a significant preoperative risk of mortality with standard surgery).
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Data presented during a late-breaking session showed procedural success in 92 of 93 patients treated at 12 centers across Europe. There were no procedural deaths, the overall 30-day mortality rate was 9.7 percent, and with experience (after three cases) the 30-day mortality rate was 7.0 percent. Approximately half of the patients received the replacement valve through a minithoracotomy (an opening between two ribs) and half through a ministernotomy (an opening through the sternum); both minimally-invasive procedures are performed without stopping the heart or penetrating the heart's ventricular wall. Most patients (83.9 percent) had been previously diagnosed with peripheral vascular disease and almost one-third had undergone previous coronary artery bypass surgery (the mean logistic EuroSCORE was 28.0 ± 15.7 indicating a significant preoperative risk of mortality with standard surgery).
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