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Milan, Italy. January, 31 2011 – Sorin Group, (Reuters Code: SORN.MI), a global medical device companyand a leader in the treatment of cardiovascular diseases, announces the commercial availability in Europe of theself- anchoring PercevalTM S aortic heart valve. The innovative
next-generation valve represents the latestinnovation
in heart valve technology.
The Perceval S Sutureless biological valve is indicated for the rapid and
minimally invasive surgical replacementof the aortic valve in patients
suffering from aortic stenosis. Aortic stenosis is the most common
acquiredvalvular heart disease in the western world and its occurrence
increases with age. The prevalence of severesymptomatic aortic stenosis is
typically reported around 3% in patients 75 years of age (this percentage
alsorises 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 2
to 3 years.
Perceval 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 valve’s functional component is made of
bovine pericardium and is mounted on a superelastic 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 1 and 2 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-commercialisation
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 advanced clinical segment,”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.
For more information, please visit:
www.sorin.com