Sorin 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 30 April 2014 ‘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 (30 day mortality and late mortality were respectively 1.5% and 4.5%), low morbidity rate and excellent hemodynamic performance (MPG and EOA at one year were 7.2 ± 4mmHg and 1.5 ± 0.5mm/cm2).
Dr Markus Thalmann from Krankenhaus Hietzing, Wien, Austria, and principal investigator of the European arm and of the US FDA study said: This study confirms the safety and effectiveness of a stentless aortic valve that has demonstrated an outstanding hemodynamic performance, durability and ease of implant through years of clinical performance in Europe."
The study included patients from 18 selected and experienced centers in Europe.
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.