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Spiral Laminar Flow (SLF™) is a proprietary platform technology developed by Tayside Flow Technologies. The Spiral Flow™ Vascular Access Graft is the second product developed from this technology platform.
The graft is a wrapped, expanded polytetrafluoroethylene (ePTFE) graft with custom features injection molded of Chronoflex polyurethane.
The distal portion of the graft contains the patented Spiral Flow Inducer, the Inducer Indicator Ring and pre-cut distal anastomotic cuff. The injection molded components of the graft are NON-REMOVABLE.
The Spiral Flow Inducer is an injection molded component running along the distal end of the graft. It should never be modified as loss of its form may cause Spiral Laminar Flow™ to not be propagated through the graft. See Technical Sheets 200 and 300 for more information on the servicing of the graft.
The Inducer Indicator Ring is palpable to the dialysis staff during graft assessment. NO CANNULATION should occur between the Inducer Indicator Ring and the venous anastomosis. See Technical Sheet 100 for more information on cannulation of the SLF™ Graft. The graft is not specifically designed for early cannulation.
The Spiral Flow™ Vascular Access Graft is handled at implant the same as all other ePTFE grafts. Therefore no technique changes are necessary.
It is highly recommended that the distal anastomosis be sewn first to aid in cutting the graft to its proper length.
Once installed, the Spiral Flow™ Vascular Access Graft will create spiral flow immediately. Spiral Laminar Flow™ is easily determined by taking a transverse color Doppler ultrasound over the distal portion of the graft or anastomosed vein. See Technical Sheet 400 for instructions on how to perform the color Doppler ultrasound study.
The process of blockage caused by neointimal hyperplasia in and near the graft-vein anastomosis is driven to a large part by disturbed or turbulent flow. The Spiral Flow™ Vascular Access Graft delivering less turbulent energy by utilizing spiral laminar flow™ delivering blood flow into the venous system like a native AV fistula should:
� improve device patency
� prolong the effective life of devices
� reduce downstream disease progression
� improve patient quality of life
See the Spiral Flow™ Vascular Graft Instructions for Use for additional information on working with the Spiral Flow™ Vascular Access Graft.
SLF Technology:
Clinical
"The following are human clinical results of the Spiral Flow™ Graft products and the Spiral Laminar Flow™ Technology platform. Immediately upon implan,, the Spiral Flow™ product begins restoring natural flow which creates the perfect baseline. Patency intervals and complication rates are optimized by "starting from normal." Even so, TFT will constantly pursue clinical studies to validate the prevalence and benefit of Spiral Laminar Flow™. We are always interested in speaking with parties interested in helping us to achieve that goal. Call us or email us at tft@tayflow.com if you have a data collection project you want to share or discuss."
1. Spiral laminar flow in arteries? Stonebridge PA, Brophy CM
2. Spiral Laminar Flow Arterial Grafts: Improved Early Clinical Results And Theoretical Basis, Vermassen F, Stonebridge PA
3. Spiral Laminar Flow: An Examination of this critical blood flow pattern and the early results of a first in man study. Vermassen F, Dick J
4. Spiral laminar flow in vivo, Stonebridge PA, Hoskins PR
5. Spiral laminar flow in the abdominal aorta: a predictor of renal impairment deterioration in patients with renal artery stenosis. Houston JG, Stephens JG
6. Below Knee Peripheral Bypass Graft Patency Trends: A Comparison, Nelson R
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