Not one to miss an opportunity of the type presented by a major congress, Italian cardiovascular technologies company Sorin Group is touting the results of the European and North American (Canada and US) cohort study on the Freedom Solo valve. Clinical findings have been aired at the annual European Association for Cardio-Thoracic Surgery (EACTS) bash.
Sorin describes Freedom Solo as a stentless biological prosthesis that provides optimum blood flow and can be implanted faster than other available stentless valves. This promotes a claimed quicker patient recovery and lower overall hospital costs. The device has been developed to address the increasing demand for tissue valves and the ever-growing worldwide use.
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. Results demonstrated low complication rates, low and stable pressure gradients, excellent left ventricular remodeling and improved patients’ functional status at three years after surgery.
“This study confirms the safety and effectiveness of this unique stentless pericardial aortic valve whose design allows simple implantation and facilitates excellent hemodynamic performance in the biggest patient population presented,” said Herko Grubitzsch, M.D. at Charité – Universitätsmedizin in Berlin, Germany, one of the main investigators of the European arm of the Freedom Solo study, which included patients from 18 European and 15 North American selected centers.
Another paper presented at EACTS was the ‘North American FDA Trial Results at one year of the Sorin Freedom Solo Pericardial Aortic Valve’. In that study, 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.
“The Freedom Solo valve demonstrated safety with no structural valve deterioration and excellent hemodynamics at one year”, said David A. Heimansohn, M.D., F.A.C.S. at St. Vincent Heart Center of Indianapolis in Indiana. “This is a very important outcome, in terms of patient compliance, that confirms Freedom Solo as a cutting-edge solution in the cardiac surgery medical device arena”, he added.
“The clinical results achieved by the Freedom Solo trials reinforces Sorin Group’s position as a leader in innovation, focused on maximizing patient safety and minimizing the impact on hospital resources and budgets”, said Michel Darnaud, President Cardiac Surgery Business Unit, Sorin Group.
Source: Sorin Groups SpA., Business Wire