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ATS 3f® Aortic Bioprosthesis

Preserve Aortic Sinuses

By using a single suture line at the annulus and tacking the commissural tabs to the sinotubular junction (STJ), the continuity between the annulus and the STJ is restored with implantation of the ATS 3f® Aortic Bioprosthesis.
Maintaining the continuity between the annulus and the STJ, without a second suture line at the sinuses, preserves sinus form and function.¹
Sinuses facilitate better vortex formation early in systole and smooth closure of the aortic vale, thereby avoiding the buildup of abnormal stress in the leaflet. ²
Turbulent flow and greater leaflet stress is a consequence of sinus loss.³
Loss of sinuses results in leaflet and aortic wall contact, greater regurgitation during a longer systole and abnormal leaflet bending during closure.²

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

Restore Physiologic Flow

Because it is tubular, the ATS 3f® Aortic Bioprosthesis restores physiologic, non-turbulent trans-prosthetic flow that is indistinguishable from flow across a native aortic valve.⁴
The ATS 3f Aortic Bioprosthesis is a stentless pericardial valve that replaces the diseased native aortic leaflets.
Since there is no bulky stent, minimal tissue is implanted achieving essentially a 1:1 annulus to orifice ratio and laminar flow, just like a native valve.

BI2-2-1_Native_3fAortic

Restore Native Valve Stress Distribution

Because it is tubular, the ATS 3f Aortic Bioprosthesis restores native valve stress distribution to the entire aortic root.⁴
The form and function of a native valve is reproduced with the implantation of the ATS 3f Aortic Bioprosthesis resulting in minimal stress at the commissures, just like a native valve.

BI2-2-1_3fTube

BI2-2-1_3fFinite

BI2-2-1_3fStress

BI2-2-1_Stress

Product Specifications

Aortic valve sizes 19mm to 29mm

Contact ATS Medical at 1-763-553-7736 for more specific product specifications.

1. Jin XY, Implications of stentless valve design and implantation techniques for aortic root geometry [abstract]. Paper presented at: Advanced Cardiac Techniques in Surgery; May 2-3, 2007; New York, NY.
2. Katayama S et al. J Thorac Cardiovasc Surg 2008; 136: 1528-35.
3. Grande KJ, et al. J Thorac Cardiovasc Surg 2000;119:753-763.
4. Cox JL, et al. J Thorac Cardiovasc Surg 2005;130(2),520-527.

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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