The "Cell-free Human Aortic Valve, Arise AV" has been approved by the German competent authority as a medicinal product (PEI.G.11766.01.1) for use in children and adults. The "Cell-free human aortic valve, Arise AV" is intended for the replacement or reconstruction of an aortic or pulmonary valve according to the clinical indication.

Clinical experience

The "Cell-free Human Aortic Valve, Arise AV" can be used safely. Clinically relevant degeneration or calcification has rarely been reported. This also applies to implantations in children and young adults.

30-year-old patient with double valve replacement (in May 2011) after previous Ross procedure at the age of 18 years A: Aorta ascendens with long aortal graft; B: Diastole; C: Systole with large opening area. (c S. Sarikouch, MRI: 1.5 T, Hannover Medical School, 2018)

Relevant publications

Horke A, Tudorache I, Laufer G, Andreas M, Pomar JL, Pereda D, Quintana E, Sitges M, Meyns B, Rega F, Hazekamp M, Hübler M, Schmiady M, Pepper J, Rosendahl U, Lichtenberg A, Akhyari P, Jashari R, Boethig D, Bobylev D, Avsar M, Cebotari S, Haverich A, Sarikouch S. Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data. Eur J Cardiothorac Surg. 2020 May 9. pii: ezaa100. doi: 10.1093/ejcts/ezaa100. PMID 32386409

Horke A, Bobylev D, Avsar M, Meyns B, Rega F, Hazekamp M et al. Paediatric aortic valve replacement using decellularized allografts. Eur J Cardiothorac Surg 2020; https://doi.org/10.1093/ejcts/ezaa119

Bobylev D, Sarikouch S, Tudorache I, Cvitkovic T, Söylen B, Boethig D, Theodoridis K, Bertram H, Beerbaum P, Haverich A, Cebotari S, Horke A. Double semilunar valve replacement in complex congenital heart disease using decellularized homografts. Interact Cardiovasc Thorac Surg. 2019 Jan 1;28(1):151-157. doi: 10.1093/icvts/ivy212. PMID 30016427