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ATS 3f Aortic Bioprosthesis in prple background

ATS 3f® Biological Valves…Tubular Design. Just Like Your Native Valve.

The ATS 3f® Aortic Bioprosthesis is an aortic valve designed to function just like a native valve. Its tubular design was inspired by how a native aortic valve forms in utero: as a tube with sides that collapse when external pressure is applied.¹ ATS 3f Enable® Aortic Bioprosthesis The ATS 3f Enable® Aortic Bioprosthesis, the second generation of the ATS 3f Aortic Bioprosthesis, is a bioprosthesis housed within a self-expanding nitinol frame that can be folded into a reduced geometry or diameter and positioned in the native valve annulus. It is positioned into the annulus with one guiding suture. The ATS 3f Enable bioprosthesis is intended to reduce surgical cross-clamp and cardio-pulmonary bypass time. The bioprosthesis is presently in clinical studies. The ATS Enable bioprosthesis is not available for sale in the United States. ATS 3f Enable® Aortic Bioprosthesis	Product Brochure The Original You Tube Animation Form Follows Function: The ATS 3f Aortic Bioprosthesis Physician Interviews Implantation Technique of the ATS 3f Aortic Bioprosthesis

1. Cox JL, et al. J Thorac Cardiovasc Surg 2005;130(2),520-527.

ATS 3f Aortic Bioprosthesis
INDICATIONS:
The ATS 3f® Aortic Bioprosthesis, Model 1000 is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

CONTRAINDICATIONS:
The ATS 3f® Aortic Bioprosthesis, Model 1000 should not be used in those patients who present with congenital bicuspid anatomy or other forms of abnormal aortic root geometry.

WARNINGS/PRECAUTIONS/SIDE EFFECTS:
Accelerated deterioration of the Model 1000 valve due to calcific degeneration may occur in children, adolescents, or young adults, or in patients with altered calcium metabolism such as patients on maintenance hemodialysis for chronic renal failure, patients with hyperparathyroidism, patients on high calcium diets, or patients requiring chronic calcium-containing drug therapy. The performance of the Model 1000 valve is, as is the case for all stentless bioprosthetic valves, dependent on accurate matching of the valve to the recipient patient’s aortic annular and sinotubular dimensions and may be adversely affected by high aortic root compliance. General complications potentially associated with the use of bioprosthetic heart valves include: leak (transvalvular, perivalvular), cardiac dysrhythmias, endocarditis, hemolysis, hemorrhage, non-structural dysfunction [NSD] (entrapment by pannus or suture, inappropriate sizing or positioning, or other), structural deterioration (intrinsic and extrinsic calcification, leaflet perforation or tear, leaflet thickening, or myxomatous degeneration), prosthesis stenosis, prosthesis regurgitation, valve thrombosis, thromboembolism.

CAUTION:
Federal law restricts this device to sale by or on the order of a physician. This device is restricted to use by a physician who has participated in specific implantation training for the ATS 3f® Aortic Bioprosthesis, Model 1000.

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