|[May 12, 2014]
Sorin Group Announces Freedom Solo FDA Study Results at the AATS 2014 Scientific Sessions
TORONTO --(Business Wire)--
Sorin Group, (MIL:SRN) (Reuters (News - Alert) Code: SORN.MI), a global medical company
and a leader in the treatment of cardiovascular diseases, is proud to
announce the results of its trial on the Freedom Solo for approval on
the US market presented at the 94th Annual Meeting of
American Association for Thoracic Surgery (AATS) in Toronto, Canada.
In the trial presented on April 30, 'One-Year Outcome on 616 Patients
Receiving a Stentless Bioprosthesis: Results from a European Multicentre
Study' researchers evaluated the safety and effectiveness of the
Freedom Solo stentless bioprosthesis in patients requiring aortic valve
replacement (AVR) with or without combined cardiac procedures.
One-year outcomes reported by M.Thalmann et.al. showed good
clinical results, with low mortality (thirty day mortality and late
mortality were respectively 1.5% and 4.5%), low morbidity rate and
excellent hemodynamic performance (MPG and EOA at 1 year were 7.2 ± 4
mmHg and 1.5 ± 0.5 mm/cm2).
"This study confirms the safety and effectiveness of a stentless aortic
valve that has demonstrated an outstanding hemodynamic performance,
durability and eas of implant through years of clinical performance in
Europe," said Markus Thalmann, M.D., Krankenhaus Hietzing, Wien,
Austria, principal investigator of the European arm and of the U.S. FDA
study, which included patients from 18 selected and experienced centers
Freedom Solo, a truly stentless and a fully biological aortic heart
valve with no synthetic material, has been in clinical use since 2004.
This unique bioprosthesis was designed to respect the aortic root
anatomy and ensure a physiological blood flow through the annulus.
"Exhibiting excellent hemodynamic performance and proven long-term
clinical outcomes, Sorin Group (News - Alert) bioprosthetic valves are the choice of
cardiac surgeons worldwide. Sorin heart valves remain at the forefront
of innovation and uphold our tradition of clinical excellence," said
Michel Darnaud, President Cardiac Surgery 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 3,750 employees worldwide, Sorin Group
focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary
products for open heart surgery and heart valve repair or replacement
prostheses) and Cardiac Rhythm Management (pacemakers, defibrillators
and non invasive monitoring to diagnose arrhythmias 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 80 countries.
For more information, please visit www.sorin.com
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