📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Creation of subcutaneous tunnels for placement of vascular grafts.
- Use during vascular reconstruction procedures in which a graft must be routed through soft tissue.
Clinical Applications
- Creating a subcutaneous tunnel for a vascular graft during coronary artery bypass surgery.
- Routing graft material during peripheral vascular bypass or reconstruction.
- Helping position a graft for treatment of limb-threatening ischemia when surgical revascularization is planned.
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.
Practical Considerations
- The product name includes standard, mid, full, and short curve configurations; the surgeon selects the curve and length based on the operative route and patient anatomy.
- It is a tunneling instrument, not the vascular graft itself, and must be compatible with the planned graft material and surgical technique.
- The instrument is used under direct surgical control; care is required to avoid injury to nerves, veins, arteries, or other structures along the tunnel.
- The FDA record does not establish MRI safety labeling for this instrument. MRI use should be determined from the current manufacturer instructions and the instrument's material composition.
- Cleaning, sterilization, inspection, and maintenance must follow the current manufacturer instructions for use. It is not an implant and is not intended to remain in the body.
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.