The results of its trial on the Freedom Solo (Sorin) for approval on the US market were presented at the 94th Annual Meeting of American Association for Thoracic Surgery (AATS) in Toronto, Canada.
In the trial: “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 with or without combined cardiac procedures.
One-year outcomes were reported by Markus Thalmann, Krankenhaus Hietzing, Vienna, Austria, showed good clinical results with low mortality (30-day mortality and late mortality were 1.5% and 4.5%, respectively), low morbidity rate and excellent haemodynamic performance (MPG and EOA at one year were 7.2±4mmHg and 1.5±0.5mm/cm2).
“This study confirms the safety and effectiveness of a stentless aortic valve that has demonstrated an outstanding haemodynamic performance, durability and ease of implant through years of clinical performance in Europe,” says Thalmann, the principal investigator of the European arm and of the US Food and Drug Administration (FDA) study, which included patients from 18 selected and experienced centres in Europe.
Freedom Solo, according to Sorin, is a stentless and a fully biological aortic heart valve with no synthetic material, has been in clinical use since 2004. The bioprosthesis was designed to respect the aortic root anatomy and ensure a physiological blood flow through the annulus.