đź“Š Evidence-Based Reference
Turbo-Elite Atherectomy Catheters Turbo Tandem System
Product: Turbo Tandem — all models and sizes
Summary: The Turbo-Elite Atherectomy Catheters by Spectranetics are used for atherectomy procedures. Cleared by the FDA via the 510k pathway, they are primarily used to treat peripheral arterial disease. Key evidence includes studies on laser and balloon angioplasty.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140775 ↗
Decision Date ?
July 23, 2014
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Turbo-Elite Atherectomy Catheters were cleared by the FDA through the 510k pathway on July 23, 2014. Manufactured by Spectranetics, they are classified as Class 2 medical devices under product code MCW.
What It Is
The Turbo-Elite Atherectomy Catheters are designed for atherectomy, a minimally invasive procedure to remove plaque from blood vessels. They utilize laser technology to ablate atherosclerotic lesions, facilitating improved blood flow in peripheral arteries.
FDA-Cleared Indications
- Treatment of peripheral vascular lesions that are suitable for laser atherectomy.
- Treatment of stenotic or occlusive lesions in peripheral arteries, including certain in-stent restenosis lesions, when consistent with the applicable device labeling.
- Use during percutaneous peripheral vascular intervention to ablate atherosclerotic or other obstructive material and facilitate restoration of blood flow.
Clinical Applications
- Laser atherectomy of peripheral arterial stenosis or occlusion.
- Treatment of peripheral arterial disease lesions during an endovascular procedure.
- Treatment of selected peripheral arterial in-stent restenosis lesions.
- Adjunctive lesion preparation before or with balloon angioplasty.
- Use with fluoroscopic imaging and compatible guidewires, sheaths, and other endovascular equipment.
Evidence Summary
The available literature includes two clinical studies registered on ClinicalTrials.gov. These studies focus on the use of laser and balloon angioplasty in treating peripheral in-stent restenosis. The studies do not specify the total number of participants or the exact date range.
Reported Outcomes
Published studies report the use of the Turbo-Elite Atherectomy Catheters in conjunction with balloon angioplasty to effectively treat peripheral in-stent restenosis. The studies suggest potential benefits in reducing restenosis rates, although specific efficacy metrics are not detailed.
Safety Profile
Reported complications include typical procedural risks associated with atherectomy, such as vessel perforation and embolization. However, the studies provided do not offer detailed safety data or incidence rates of these complications.
Evidence Limitations
The evidence is limited by the lack of detailed study outcomes and safety data. Further research is needed to quantify efficacy and safety metrics, as well as to explore long-term outcomes and comparative effectiveness against other treatment modalities.
Practical Considerations
- The catheter is advanced through a vascular access sheath over a compatible guidewire under fluoroscopic guidance; the exact catheter diameter, working length, and guidewire requirements vary by model.
- Laser atherectomy requires careful control of catheter advancement, laser activation, blood flow, and contrast or saline technique according to the manufacturer's instructions for use.
- It is not a permanent implant. The catheter is removed after the procedure and does not provide long-term mechanical scaffolding.
- MRI safety depends on the specific catheter model and its labeling; because the device is used during a procedure and is not left implanted, the manufacturer's MRI information should be checked before scanning.
- Potential complications include vessel dissection or perforation, thrombosis, distal embolization, bleeding at the access site, infection, contrast reaction, and restenosis. Patient selection and contraindications should follow the current labeling.
Frequently Asked Questions
What are the clinical indications for Turbo-Elite Atherectomy Catheters?
The device is indicated for use in atherectomy procedures to treat peripheral arterial disease, particularly in cases of in-stent restenosis.
What outcomes have been reported in clinical studies?
Studies suggest the device is effective in reducing restenosis rates when used with balloon angioplasty, though specific metrics are not detailed.
What complications have been reported?
Reported complications include vessel perforation and embolization, typical of atherectomy procedures, though detailed safety data is lacking.
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.