Pulmonary valve bioprosthesis SAPIEN XT Pulmonic

bovine tissuecobalt-chromiumsutureless

Product overview A proven technology to successfully delay open heart surgery in patients with pulmonary valve disease. The Edwards SAPIEN XT transcatheter heart valve is now approved for use in pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit. Important safety information Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System – Pulmonic Indications: The Edwards SAPIEN XT transcatheter heart valve (THV) systems are indicated for use in pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention and: pulmonary regurgitation ≥ moderate and/or mean RVOT gradient ≥ 35 mmHg. Contraindications: The THV and delivery systems are contraindicated in patients with inability to tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis. Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices . There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Assessment for coronary compression risk prior to valve implantation is essential to prevent the risk of severe patient harm. Incorrect sizing of the THV may lead to paravalvular leak, migration, embolization and/or RVOT rupture. Accelerated deterioration of the THV may occur in patients with an altered calcium metabolism.