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Turbohawk Peripheral Plaque Excision System
Product: TurboHawk — all models and sizes
Summary: The TurboHawk Peripheral Plaque Excision System is a directional atherectomy device used primarily for treating peripheral artery disease (PAD) in the lower extremities. Key evidence highlights its use in combination with drug-coated balloon angioplasty for improved patency rates.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111723 ↗
Decision Date ?
October 27, 2011
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
3 studies
The TurboHawk Peripheral Plaque Excision System was cleared by the FDA through the 510(k) pathway on October 27, 2011. It is manufactured by Ev3 and classified as a Class 2 device under product code MCW.
What It Is
The TurboHawk Peripheral Plaque Excision System is a directional atherectomy device designed to excise atherosclerotic plaque from peripheral arteries. It is intended for use in patients with peripheral artery disease (PAD) to restore blood flow in the lower extremities.
FDA-Cleared Indications
- Treatment of peripheral vascular disease in the lower-extremity arteries.
- Excision of atherosclerotic plaque from peripheral arteries using directional atherectomy.
- Use in peripheral arteries appropriate for the system's labeled catheter and access specifications.
Clinical Applications
- Directional atherectomy of atherosclerotic lesions in the femoral arteries.
- Directional atherectomy of atherosclerotic lesions in the popliteal arteries.
- Plaque removal during an endovascular treatment strategy for lower-extremity peripheral artery disease.
- Use before adjunctive balloon angioplasty when additional treatment is clinically indicated.
Evidence Summary
The available literature includes a mix of randomized controlled trials, prospective studies, and case series, with a total of 8 studies identified. The studies span from 2016 to 2025, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the TurboHawk system, when used in combination with drug-coated balloon angioplasty, can improve patency rates and limb salvage in patients with peripheral artery disease. Mid-term outcomes indicate efficacy in treating femoral popliteal artery lesions with varying GLASS grades.
Safety Profile
Reported complications include typical procedural risks such as arterial dissection and restenosis. However, the studies reviewed do not provide detailed safety data, indicating a need for further research into long-term safety outcomes.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to explore the device's efficacy across diverse patient populations.
Practical Considerations
- The system is catheter-based and is generally introduced through a percutaneous vascular access site under fluoroscopic imaging.
- The available catheter size, lesion dimensions, vessel diameter, tortuosity, and guidewire or sheath compatibility must match the specific device model and labeling.
- Atherectomy may be followed by balloon angioplasty, stenting, or another treatment if residual stenosis, dissection, or flow limitation remains.
- Potential complications include embolization, perforation, dissection, thrombosis, bleeding at the access site, and vascular injury.
- MRI safety depends on the specific device components and whether they remain in the body; the applicable device labeling should be checked before MRI.
Linked Studies (3)
PubMed • 2024
Study on mid-term outcomes of atherectomy for patients with femoral popliteal artery lesions with different Global Limb Anatomic Staging System grades.
PeerJ
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
View Source →ClinicalTrials.gov
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
View Source →Frequently Asked Questions
What are the clinical indications for TurboHawk Peripheral Plaque Excision System?
The device is indicated for the excision of atherosclerotic plaque in patients with peripheral artery disease, particularly in the lower extremities.
What outcomes have been reported in clinical studies?
Studies have reported improved patency rates and limb salvage when the device is used in combination with drug-coated balloon angioplasty.
What complications have been reported?
Reported complications include arterial dissection and restenosis, though detailed safety data 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.