MILAN--(BUSINESS WIRE)--Sorin Group, (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today 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.
“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.
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.
“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.
Freedom Solo is a stentless biological prosthesis that provides optimum blood flow and can be implanted faster than other available stentless valves. This promotes a 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.
About Sorin Group
Sorin Group (http://www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With over 3,500 employees worldwide, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). Every year, over one million patients are treated with Sorin Group devices in more than 100 countries.
For more information, please visit www.sorin.com.