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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 suggests its effectiveness in improving patency rates when combined with drug-coated balloon angioplasty.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K093301 ↗
Decision Date ?
November 6, 2009
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
3 studies
The TurboHawk Peripheral Plaque Excision System was cleared by the FDA via the 510(k) pathway on November 6, 2009. It is manufactured by Ev3 and classified as a Class 2 medical device.
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 de novo or restenotic lesions in peripheral arteries affected by atherosclerotic disease.
- Removal of plaque from peripheral arteries to help restore or improve blood flow.
- Use in lower-extremity peripheral arteries, including the femoral and popliteal arteries, according to the applicable device labeling.
Clinical Applications
- Directional atherectomy of atherosclerotic lesions in the femoral artery.
- Directional atherectomy of atherosclerotic lesions in the popliteal artery.
- Treatment of peripheral artery disease lesions before or in combination with balloon angioplasty when consistent with the device labeling.
- Plaque debulking during an endovascular lower-extremity revascularization procedure.
Evidence Summary
The available literature includes a mix of randomized controlled trials, prospective studies, and clinical trials, with a total of 8 studies identified. The studies span from 2016 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the TurboHawk system, when used in combination with drug-coated balloon angioplasty, improves patency rates and limb salvage in patients with PAD. The PANDA trial highlighted its effectiveness in lower extremity arterial disease, while other studies demonstrated its utility in treating femoral popliteal artery lesions.
Safety Profile
Reported complications include arterial dissection and restenosis, which are common in atherectomy procedures. However, the overall safety profile is consistent with other devices in its class, with no new safety concerns identified in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations, which may affect the generalizability of the findings. Further research is needed to explore long-term outcomes and to compare the TurboHawk system with other atherectomy devices.
Practical Considerations
- The system is advanced over a guidewire through vascular access, commonly from the femoral artery, under fluoroscopic guidance.
- The catheter size, working length and lesion compatibility must be matched to the target vessel and the specific system configuration.
- Directional atherectomy requires controlled positioning and plaque collection; operators must follow the device instructions for use regarding passes, capture and removal of excised material.
- Contraindications and limitations include vessels or lesions outside the labeled anatomy, inability to cross the lesion safely, severe vessel tortuosity and situations in which endovascular access is not appropriate.
- MRI safety depends on the specific catheter and any retained or associated components; the applicable labeling should be checked before MRI. The device is normally removed after the procedure.
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, which are typical for atherectomy procedures.
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.