Medtronic Inc, the world's biggest medical technology company, showed a lot of promise today after data from a study showed that its minimally invasive CoreValve system which takes the place of ailing aortic heart valves resulted to a much higher rate of survival after the procedure compared to those who underwent open heart surgery. The patients were considered at high risk of death at the time of the surgery, Reuters reported.
Researchers, who presented their findings at the American College of Cardiology scientific meeting in Washington, said that in the Phase III trial of CoreValve participated in by 795 patients, the death rate was 14.2%. This was lower compared to those who underwent surgery which had a 19.1% rate of death. This is considered a statistically significant finding. In addition, those who were treated with CoreValve did not exhibit increased risk of stroke compared to those who underwent surgery. Early in the clinical testing phase, one of the major issues was if transcatheter aortic valve replacement or TAVR would lead to a higher incidence of stroke, the report said.
CoreValve trial Co-Principal Investigator Dr. David Adams said, "I think the results were outstanding."
With TAVR systems, patients don't have to undergo invasive open heart surgery that usually involve a longer period of stay in the hospital. In this procedure, a catheter that is connected through an artery to the heart is used to position the new valve, the report said.
During the early stages of the procedure, Adams said the question if TAVR could be a potential surgery alternative was paramount. Now, however, he said TAVR "might be better." He added, "We're making continual progress. It's not only an alternative but may be a preferable alternative." US approval for the CoreValve system was given earlier than expected in January to treat extreme-risk patients who considered too weak to proceed with open heart surgery, the report said.
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