Indications: For use in reconstructive procedures for the repair of congenital or acquired cardiac and great vessel malformations or pathology.
Contraindications: Patients undergoing chronic hemodialysis have an increased tendency towards calcification of tissue valved conduits.
Warnings/Precautions/Adverse Events: Preclot valved conduits to minimize hemorrhage through the conduit. Reported complications include: valvular thrombosis, thromboembolism, calcification and fibrosis, valvular insufficiency, perivalvular insufficiency, valvular stenosis, leaflet perforation, significant transvalvular pressure gradients in small size bioprostheses, valve contamination, development of intraluminal peel, and hemorrhage through the graft and anastomotic sites.
For additional information, please refer to the Instructions For Use provided with the product.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.