Date: 2014-10-15
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 28th Annual Meeting of European Association for Cardio-Thoracic Surgery (EACTS) in Milan, Italy
Company: Sorin (Italy)
Product: Freedom Solo valve
Action
mechanism: Freedom Solo is a stentless biological prosthesis that provides optimum blood flow and can be implanted faster than other available stentless valves.
Disease: aortic valve replacement
Therapeutic area: Cardiovascular diseases
Country:
Trial details:
Latest
news: * On October 15, 2014, Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced the results of the European and North American (Canada and US) cohort study on the Freedom Solo valve at the 28th Annual Meeting of European Association for Cardio-Thoracic Surgery (EACTS) in Milan, Italy. In the presentation entitled ‘Clinical and hemodynamic outcomes in 804 patients receiving the Freedom Solo stentless aortic valve: results from an international prospective multicenter study’, researchers evaluated the safety and effectiveness of the bioprosthesis in a large population including European, Canadian and U.S. patients requiring aortic valve replacement (AVR) with or without concomitant cardiac procedures. The study showed successful clinical results, with low early and late mortality up to three years after surgery. Despite the increased risk profile and advanced age of the patient population, the 30-day mortality rate was 1.7 percent, overall survival was 82.6 percent and freedom from valve-related death was 95.5 percent at 3 years. The excellent performance of the Freedom Solo heart valve was confirmed by a number of positive results, including low complication rates, low and stable pressure gradients, excellent left ventricular remodeling and improved patients’ functional status at three years after surgery. Similarly, very good performance results were reported in the ‘North American FDA Trial Results at one year of the Sorin Freedom Solo Pericardial Aortic Valve’. One-year results of the 249 patients in the North American arm of the Freedom Solo study showed excellent hemodynamic performance with an overall mean gradient of 7.86 mmHg and a mean effective orifice area of 1.73 cm2 with 95 percent of patients in NYHA class I or II. Moreover, patient outcomes were significantly improved with no valve-related death, no hemolysis and no structural valve deterioration at one year.
