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vein valve cutter
American Edwards Laboratories
Summary: The vein valve cutter by American Edwards Laboratories is a medical device used primarily for valvular disruption in venous procedures. Key evidence highlights its use in saphenous vein bypass grafts.
FDA Clearance Information
Pathway
510K
Number
K862724 ↗
Decision Date
January 2, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The vein valve cutter was cleared by the FDA through the 510(k) pathway on January 2, 1987. It is manufactured by American Edwards Laboratories and classified as a Class 2 device.
What It Is
The vein valve cutter is a surgical instrument designed to disrupt venous valves, facilitating blood flow in procedures such as in situ saphenous vein bypass. It is intended for use by vascular surgeons in clinical settings.
Clinical Applications
Commonly used in vascular surgeries, the vein valve cutter is employed in procedures requiring the removal or disruption of venous valves, such as in situ saphenous vein bypass grafts and arteriovenous fistula creation.
Evidence Summary
The literature includes 12 studies ranging from 1989 to 1994, encompassing various study types such as prospective and retrospective analyses. These studies focus on the device's efficacy and safety in clinical applications.
Reported Outcomes
Published studies report that the vein valve cutter is effective in achieving valvular disruption during in situ saphenous vein bypass procedures. The device has been evaluated for its ability to maintain venous hemodynamics and prevent valve incompetence.
Safety Profile
Reported complications include potential detachment of associated instruments during procedures, as noted in some studies. Overall, the device is considered safe when used according to established surgical protocols.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials directly comparing different valve cutters. Further research is needed to establish long-term outcomes and optimize procedural techniques.
Frequently Asked Questions
What are the clinical indications for vein valve cutter?
The vein valve cutter is indicated for use in procedures requiring venous valve disruption, such as in situ saphenous vein bypass and arteriovenous fistula creation.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful valvular disruption and maintenance of venous hemodynamics using the vein valve cutter.
What complications have been reported?
Safety data from evidence indicate potential complications such as instrument detachment during procedures, though these are generally manageable with proper technique.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.