Surgical Valve Replacement Heart Valve Therapies
The Medtronic tissue valve expertise benefits from more than 40 years of experience, research, and skill — allowing us to provide the world with not only choice, but with advanced features that make a difference in patients' lives. Our third generation of tissue valve technology brings you AOA™ tissue treatment,* the Physiologic Fixation process,* and now, the Cinch™ Implant System — demonstrating our commitment to innovation.
Age, calcium metabolism and glutaraldehyde pretreatment all contribute to the failure of tissue valves. AOA treatment, used on the Mosaic™ bioprosthesis and the Freestyle™ Aortic Root bioprosthesis, is Medtronic's biochemical approach to mitigating calcification in the wall and leaflets of tissue valves.1 It is distinguished from other tissue treatments by its unique interaction and covalent bonding with the free aldehydes of glutaraldehyde.
Our exclusive Physiologic Fixation process mitigates biomechanical failures and promotes long-term valve durability by:
The Cinch System, exclusively offered with the Mosaic and Hancock™ II aortic and mitral bioprostheses, further capitalizes on the valve's flexible stent to facilitate valve implementation, particularly through a tight sinotubular space. It also:
Medtronic Open Pivot™ mechanical heart valves bring something fundamentally different to bileaflet valve design. Unlike valves with a conventional cavity pivot hinge design, Medtronic Open Pivot valves have no recesses or cavities where potential thrombogenesis can occur.4,5 In-vitro testing demonstrates that the Medtronic Open Pivot design reduces shear stress and turbulence through the pivot area.6 Clinical results show excellent thrombogenic and hemodynamic performance7,8 and outstanding durability and implantability.7-9 In addition, several patient studies show that Medtronic Open Pivot valves are remarkably quiet.10
The Medtronic Open Pivot™ Aortic Valved Graft (AVG) unites the proven performance of the Medtronic Open Pivot Heart valve with leading graft technology for exceptional implantability. This valved conduit has no tapers or pleats, allowing for easy anastomosis anywhere on the graft.
Current techniques and strategies for correction of cardiac anomalies of the RVOT include surgical repair and/or replacement of the pulmonary valve. These techniques include surgical implantation of bioprosthetic conduits or valves, or replacement via transcatheter technologies. A bioprosthetic conduit can consist of woven polyester tubes as supportive housing for glutaraldehyde-fixed porcine or bovine pericardial valves. Other surgeons prefer to implant a non-valved conduit or homograft, or to perform a valvuloplasty, thereby establishing a connection between systemic arteries and the pulmonary artery.
The Streamline leads integrate more than 50 years of scientific and technological expertise from Medtronic, the world leader in pacing. Designed for temporary pacing and sensing during and after cardiac surgery, Streamline leads are available in either bipolar or unipolar configurations for ventricular or atrial applications in adult or pediatric populations.
Most Streamline temporary pacing leads feature a sutureless fixation coil, which minimizes tissue trauma during lead insertion and removal. Our discrete electrode technology provides consistent and reliable sensing and pacing.
Chen W, et al. Mechanism of Efficacy of 2-Amino Oleic Acid for Inhibition of Calcification of Glutaraldehyde-Pretreated Porcine Bioprosthetic Heart Valves. Circulation. 1994;90:323-9.
Christie GW. Anatomy of aortic heart valve leaflets: The influence of glutaraldehyde fixation on function. Eur J Cardiothorac Surg. 1992;6(suppl):S25-33.
Schoen FJ, Levy RJ. Tissue heart valves: Current challenges and future research perspectives. J Biomed Mater Res. 1999;47:439-465.
Kelly SGD, Verdonck PR, Vierendeels JAM, et al. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Int J Artif Organs. 1999;22:754-763.
Emery RW, Petersen RJ, Kersten TE, et al. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Heart Surgery Forum. 2001;4(4):346-353.
Dumont K, Vierendeels J, Kaminsky R, van Nooten G, Verdonck P, Bluestein D. Comparison of the hemodynamic and thrombogenic performance of two bileaflet mechanical heart valves using a CFD/FSI model. J Biomech Eng. 2007 Aug;129(4):558-565.
ATS Medical, Inc. Pre-market Approval Application – Summary of Safety and Effectiveness: 2000. Washington D.C.: U.S. Food and Drug Administration; 2000.
Sezai A, Hata M, Niino T, et al. Fifteen years of experience with ATS mechanical heart valve prostheses.J Thorac Cardiovasc Surg. 2010;139:1494-1500.
Sezai A, Shiono M, Orime Y, et al. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Ann Thorac Surg. 2000;69:507-512.
No clinical data are available that evaluate the long-term impact of AOA tissue treatment and the Physiologic Fixation process in patients.
The Contegra pulmonary valved conduit is approved for use in the United States as a Humanitarian Use Device.