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Saphenous Vein Distention System
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Product Goals
PREVENTS OVERDISTENTION OF THE SAPHENOUS VEIN DURING CORONARY ARTERY BYPASS GRAFTING
The Saphenous Vein Distention System (SVDS) is designed to prevent overdistention of the saphenous vein during removal. Overdistention can result in endothelial damage and further complications such as thrombosis of the graft, occlusive subendothelial hyperplasia, accelerated graft atherosclerosis or a combination of these complications.
The Saphenous Vein Distention System was designed to avoid these complications by limiting the internal pressure within the vein by means of a pressure limiting balloon and assembly.
Each SVDS comes complete with:
- Pressure limiting balloon reservoir, 2 sizes available
- Sterile vein storage tray
- Supplied sterile in a double blister pack
- Includes instructions for use
- Supplied 5 units to a carton
- SVDS 200 (color coded Green)
- SVDS 300 (color coded Blue)
Technical Data
General method of usage
The cannula is firstly inserted into the vein and ligated. The stopcock is attached to the balloon reservoir. The syringe is filled with irrigation fluid and then attached to the free end of the stopcock. The balloon is then primed with fluid from the syringe. The balloon reservoir is then attached to the ligated cannula and all residual air is then flushed from the vein and balloon. After clamping the open end of the vein, the balloon is slowly inflated with the syringe's contents and the stopcock closed. The balloon now acts as a reservoir which continually fills the vein at a constant limited pressure. The surgeon now has the use of both hands to secure leaking side branches and manipulate the vein or balloon if necessary to overcome localized spasm.
Full instructions for use are included with each Saphenous Vein Distention System.
Materials
All materals used in the manufacture of the Saphenous Vein Distention System have been biologically and chemically analyzed to current ISO standards and approved for use in the manufacture of this medical device.
CE marking is carried out in accordance with the Medical Device Directive 93/42/EEC.
Sterilization by EtO in an ISO approved facility to current ISO/EN standards.
Procedures
Clinical Papers
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