Durable, Unique & Designed to Mimic Natural Anatomy
Clinical studies show a healthy mitral annulus is saddle shaped.1-4 While traditional rigid rings may flatten the natural saddle shape, causing greater tension on chordae and leaflets,5 the innovative St. Jude Medical Rigid Saddle Ring is designed to mimic the shape of a healthy mitral annulus.
The restoration and preservation of the natural anatomy is achieved through key product features:
-
Full three dimensional ring creates a natural saddle shape
-
15% annular height-to-commissural width ratio mimics a healthy mitral annulus4
-
Complete titanium alloy core steadfastly maintains anatomical shape and provides remodeling
 |
 |
Traditional Rigid Ring |
St. Jude Medical Rigid Saddle Ring 3D Shape
|
“When implanted, the (traditional) rigid and semi-rigid devices only restore the annular geometry in two dimensions. The height of the annulus is obliterated diminishing leaflet curvature and potentially placing increased stress and subsequent strain on the repair.”5
“A saddle-shaped annulus redistributes the forces on the chords by altering coaptation geometry, leading to an optimally balanced anatomic/physiologic configuration.”6
“A saddle-shaped annuloplasty ring may increase mitral valve repair durability by reducing leaflet and chordal strain.”4
Clinical benefits for patients. Ease of implant for physicians.
In addition to the potential clinical advantages resulting from its natural saddle shape, the St. Jude Medical Rigid Saddle Ring incorporates proprietary technologies that facilitate suturing and ease implantation, offering surgeons a unique repair solution designed to deliver a full range of benefits such as:
-
Redistribution of leaflet stress and chordae tension through saddle-shaped remodeling4,6
-
Increased repair durability (through leaflet and chordal stress reduction)4
-
Encouragement of tissue in-growth through the use of a polyester double-velour cuff7,8
-
Facilitation of suturing with the EZ Suture Cuff supported by a unique triangular core
The St. Jude Medical Rigid Saddle Ring accessories are designed for smooth implantation, with important usablity features such as:
- One-step delivery system, facilitating easy implanatation
- Malleable sizers, malleable handle, and extension handles, which bend easily and add maneuverability
- Clear, well-marked holder that facilitates visibility and ring release
- Ergonomic handles and sizers; enhancing usability
References
1Levine RA, Handshumacher MD, Sanfilippo AJ, et. al. Three-dimensional echocardiographic reconstruction of the mitral valve with implications for the diagnosis of mitral valve prolapse. Circulation. 1989;80:589-598.
2Gorman JH, Gupta KB, Streicher JT, et al. Dynamic three-dimensional imaging of the mitral valve and left ventricle by rapid sonomicrometry array localization. J Thorac Cardiovasc Surg 1996;112:712-26.
3Flachskampf FA, Chandra S, Gaddipatti A, et al. Analysis of shape and motion of the mitral annulus in subjects with and without cardiomyopathy by echocardiographic 3-dimensional reconstruction. J Am Soc Echocardiogr 2000;13:277-87.
4Salgo IS, Gorman JH, Gorman RC, et al. Effect of Annular Shape on Leaflet Curvature in Reducing Mitral Leaflet Stress. Circulation. 2002; 106:711-717.
5Gorman JH, Jackson BM, et al. Effect of regional ischemia on mitral valve annular saddle shape and function. Ann Thorac Surg. 2004;77:544-8.
6Jimenez JH, Yoganathan AP, et al. Effects of a saddle shaped annulus on mitral valve function and chordal force distribution: An in vitro Study. Annals of Biomedical Engineering. Vol. 31, pp. 1171-1181, 2003.
7Haverich, WM, Stegmann, HO, et al. Experimental and clinical experiences with double velour woven Dacron prostheses. Thorac. cardiovasc. Surgeon 34 (1986) 52-53.
8Sato, O, Tada, Y, et al. The biologic fate of dacron double velour vascular prostheses – A clinicopathological study. Japanese Journal of Surgery, 1989;19(3):301-311.