Pulmonary valve bioprosthesis SAPIEN 3

titaniumbovine tissuepediatric

Available for the treatment of pediatric and adult patients with dysfunctional RVOT conduit or surgical bioprosthetic valve in the pulmonic position. Delayed surgical intervention A less invasive alternative to surgery for patients with a history of pulmonary valve intervention. 100% Freedom from surgical re-intervention at 1 year* Freedom from reintervention with transcatheter pulmonic valve replacement (TPVR) or valve-in-valve at 1 year* Excellent clinical performance The major risks associated with the transcatheter pulmonic valve procedure include death, heart damage potentially requiring surgery, bleeding, blood vessel complications, and irregular heart beat. 0% All cause death at 1 year† (n=51)^ Endocarditis at 1 year (n=51)^ Valve frame fracture at 1 year (n=51)^ 98.1% Device success rate (n=53/54)†^ 93% None/trace paravalvular regurgitation at 1 year (n=47)^ ^(n=56) COMPASSION S3 trial results using the 20, 23, 26, and 29 mm SAPIEN 3 valve in dysfunctional RVOT conduit or surgical heart valve, valve implant population † Device success is a composite of Single THV implanted in the desired location RV-PA peak-to-peak gradient < 35 mmHg post implantation Less than moderate PR by discharge TTE (or earliest evaluable TTE) Free of explant at 24 hours post implantation Skirt Polyethylene terephthalate (PET) outer skirt is designed to minimize paravalvular leak Valve tissue Utilizes the same bovine pericardium tissue and processes** as Edwards surgical valves Frame design Enhanced frame geometry for low profile delivery Edwards SAPIEN 3 transcatheter pulmonary valve (TPV) system with Alterra adaptive prestent