Sorin Group Gets European CE Mark Approval for Self Anchoring Sutureless Aortic Heart Valve
Posted Feb 01 2011 7:28pm
The product approved is for aortic valve replacement in the heart for patients suffering from aortic stenosis. Cardiac chamber catheterization provides a definitive diagnosis for the condition and it can also be diagnosed with an ECG. The best diagnosis is usually from an echocardiogram or an ultra sound of the heart, a non invasive procedure. The valve replacement is done without the use of a stent and requires no sutures to put into place. Heart valves are certainly becoming complicated too with a big number on the market as they become more specific to meet the patient’s needs. BD
Milan, Italy, 31 January 2011 –Sorin Group , (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announces the commercial availability in Europe of the self-anchoring Perceval(TM) S aortic heart valve. The innovative next-generation valve represents the latest innovation in heart valve technology.
The Perceval(TM) S Sutureless biological valve is indicated for the rapid and minimally invasive surgical replacement of the aortic valve in patients suffering from aortic stenosis. Aortic stenosis is the most common acquired valvular heart disease in the Western world and its occurrence increases with age. The prevalence of severe symptomatic aortic stenosis is typically reported around 3% in patients 75 years of age (this percentage also rises steeply with increasing age). The prognosis is poor for patients with severe symptomatic aortic stenosis and if after the onset of symptoms the patient remains untreated, the average survival is short -- often only two to three years.
Perceval(TM) S is a surgical aortic valve with a unique self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place, therefore representing an evolution beyond traditional bioprostheses. The valves’ functional component is made of bovine pericardium and is mounted on a super-elastic alloy frame. This state-of-the-art system builds on a clinically proven stentless aortic pericardial valve implanted in over 10,000 patients with proven durability and optimal hemodynamics. Clinical results in the first 180 patients implanted with Perceval S show a significant reduction in surgical procedural time for both isolated and complex aortic valve replacement with aortic cross-clamp times typically reduced by at least 50%. Perceval S leverages the reliability of gold-standard cardiac surgical results. The hemodynamic performance was outstanding with low pressure gradients and large effective orifice areas at one and two years follow-up. To date, 25 cardiac surgery centers throughout Europe have implanted the Perceval S valve in over 500 total patients as part of the pre-commercialization clinical studies.
“We are delighted to receive the CE Mark approval for this revolutionary technology. We are dedicated to providing cardiac surgeons worldwide with high-performing, innovative therapeutic solutions that will enhance their practice and advance the treatment of cardiovascular diseases. This further strengthens our leadership in heart valve replacement technologies and gives us a competitive advantage in this cutting-edge arena,” said Davide Bianchi, President Heart Valves Business Unit, Sorin Group.
About Sorin Group Sorin Group (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 3,600 employees worldwide, Sorin Group focuses on three major therapeutic areas that include: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.