Indications, Safety, and Warnings

Hancock Porcine Valved Conduits

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.

Hancock Apical Left Ventricle Connectors

Indications: The Hancock Apical Left Ventricle Connector, used in conjunction with Hancock Model 105 Valved Conduit (low porosity), provides an alternate method for relief of left ventricular hypertension in patients with severe left ventricular outflow tract obstruction due to hypoplasia of the aortic root, hypoplasia of the aortic annulus, or acquired problems secondary to aortic valve replacement, which cannot be relieved through conventional techniques.

Contraindications: The Hancock Apical Left Ventricle Connector is contraindicated for patients presenting with any of the following conditions:

• left ventricular aneurysm
• thrombosis
• severe aortic valve reflux

Warnings/Precautions/Adverse Events: The potential for interstitial blood loss exists, particularly in patients with hemodilution or clotting factor deficiencies. Minimize serious bleeding complications by preclotting the connector and/or valved conduit. It is recommended that patients with significant left ventricular hypertrophy be studied by echocardiography. Thromboembolism, while infrequent, has been reported. Significant reduction in coronary and cerebrovascular circulation may occur when intrinsic disease is present in these systems. Caution: Do not use if severe coronary insufficiency, severe or symptomatic carotid occlusive disease, or thoracic aortic aneurysmal diseases are present.

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.