Developers: | Medtronic (Medtronik) |
Branches: | Pharmaceutics, medicine, health care, Medical centers |
Avalus — the pericardiac aortal valve developed by Medtronic company intended for implantation to people with heart troubles. The valve is installed to patients with insufficient blood circulation in a cardiac muscle and pathological processes in heart vessels. As of October, 2016 Avalus is not approved for commercial use, tests are conducted.
2016: Successful tests
At the beginning of October, 2016 the Medtronic company told about successful clinical trials of the pericardiac aortal Avalus valve. The statement was made at the 30th annual conference of the European association of cardiothoracic surgeons (European Association for Cardio-Thoracic Surgery, EACTS).
About 1300 patients from 40 clinical centers located in Europe, the USA, Canada and Japan took part in testing of Avalus. This research in Medtronic is called one of the largest, complete and modern in the field of surgical prosthetics of the aortal valve.
During EACTS analysis results of 270 patients according to the results of one year of tests were provided. During the research at the vast majority of participants (91%) the insignificant risk of death at open heart operations is recorded. In 8% cases there was an average risk, only in 1% — high. During testing 3.6% of patients died, and warm death came at 1.1% of patients. The producer calls these indicators of death rate low, considering high danger of the heart diseases requiring replacement of heart valves.
In the first year of a research the thrombembolia developed at 2.2% of patients, an endocarditis — at 1%, perivalvulyarny leak — at 0.5%, moderate and big hemorrhage — at 3.7% and 2.7% respectively. Thrombosis, hemolysis, heavy okoloklapanny leakage and changes of structure of the valve was not observed.
Besides, at Avalus carriers haemo dynamics indicators improved, and at three quarters of patients the functional class of heart failure on NYHA on one or two positions improved.[1]