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vascular graft tunneler-standard curve mid curve full curve short standard curve vascular graft tunneler accessories
Thoratec Laboratories
Summary: The vascular graft tunneler by Thoratec Laboratories is used for creating subcutaneous tunnels for vascular grafts. It is FDA 510k cleared with evidence supporting its use in coronary and limb-threatening ischemia surgeries.
FDA Clearance Information
Pathway
510K
Number
K001926 ↗
Decision Date
September 22, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The vascular graft tunneler was cleared by the FDA via the 510k pathway on September 22, 2000. It is manufactured by Thoratec Laboratories and classified as a Class 2 device.
What It Is
The vascular graft tunneler is a surgical instrument designed to facilitate the creation of subcutaneous tunnels for the placement of vascular grafts. It is used in procedures requiring the rerouting of blood flow, such as coronary artery bypass grafting.
Clinical Applications
Commonly used in coronary artery bypass grafting and surgeries addressing critical limb-threatening ischemia, the device aids in the precise placement of grafts to restore adequate blood flow.
Evidence Summary
The literature includes 10 studies, ranging from 2022 to 2024, encompassing various study types such as RCTs and retrospective analyses. These studies investigate outcomes in coronary and peripheral vascular applications.
Reported Outcomes
Published studies report that the vascular graft tunneler is associated with acceptable early and mid-term outcomes in coronary and limb-threatening ischemia surgeries. The use of drug-eluting stents and biosynthetic grafts in conjunction with the tunneler has shown promising results in improving graft patency and reducing failure rates.
Safety Profile
Reported complications include typical surgical risks such as infection and graft failure. However, the studies reviewed did not provide detailed safety data specific to the tunneler itself.
Evidence Limitations
The evidence is limited by the lack of long-term outcome data specific to the tunneler. Further research is needed to evaluate its performance in diverse patient populations and its long-term efficacy and safety.
Frequently Asked Questions
What are the clinical indications for the vascular graft tunneler?
The device is indicated for use in creating subcutaneous tunnels for vascular grafts in coronary artery bypass and limb-threatening ischemia surgeries.
What outcomes have been reported in clinical studies?
Studies report acceptable early and mid-term outcomes, with improved graft patency when used with drug-eluting stents and biosynthetic grafts.
What complications have been reported?
Reported complications include surgical risks such as infection and graft failure, though specific safety data for the tunneler is limited.
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.