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Turbohawk Plus Directional Atherectomy System
Product: TurboHawk Plus — all models and sizes
Summary: The TurboHawk Plus Directional Atherectomy System is a device used for atherectomy in peripheral arterial disease. It is FDA 510k cleared and supported by three clinical studies, focusing on its use in treating femoropopliteal artery lesions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K212027 ↗
Decision Date ?
August 24, 2021
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
3 studies
The TurboHawk Plus Directional Atherectomy System was cleared by the FDA via the 510k pathway on August 24, 2021. It is manufactured by Medtronic and classified as a Class 2 medical device.
What It Is
The TurboHawk Plus is a directional atherectomy system designed to remove plaque from peripheral arteries. It is intended for use in patients with peripheral arterial disease to restore blood flow by excising atherosclerotic lesions.
FDA-Cleared Indications
- Treatment of peripheral arterial disease involving atherosclerotic lesions in peripheral arteries.
- Directional atherectomy to excise plaque and help restore blood flow.
- Use in lesions of the femoropopliteal arteries, including the superficial femoral and popliteal arteries, as described by the device labeling.
Clinical Applications
- Directional atherectomy of atherosclerotic lesions in the superficial femoral artery.
- Directional atherectomy of atherosclerotic lesions in the popliteal artery.
- Plaque removal during an endovascular procedure for symptomatic peripheral arterial disease.
- Lesion preparation before adjunctive balloon angioplasty or other endovascular treatment, when consistent with the device labeling and treatment plan.
Evidence Summary
The available literature includes three studies registered on ClinicalTrials.gov. These studies explore the use of atherectomy followed by drug-coated balloon angioplasty, focusing on long, calcified femoropopliteal artery lesions.
Reported Outcomes
Published studies report the effectiveness of the TurboHawk Plus in excising plaque and improving arterial patency. However, specific outcome metrics such as restenosis rates or long-term patency are not detailed in the provided evidence.
Safety Profile
Reported complications include typical procedural risks such as arterial dissection and embolization. The studies do not provide detailed safety outcomes, indicating a need for further safety data.
Evidence Limitations
The evidence is limited by the lack of detailed outcome and safety data. Further research is needed to establish long-term efficacy and safety profiles, as well as to explore outcomes in diverse patient populations.
Practical Considerations
- The system is used through vascular access under fluoroscopic imaging, typically with local anesthesia and procedural sedation when needed.
- The treating physician must confirm that the target vessel size, lesion characteristics, access route, and device specifications are compatible with the labeled instructions for use.
- Atherectomy may be followed by balloon angioplasty, stent placement, or other treatment depending on residual narrowing, dissection, embolization risk, and blood flow.
- Potential complications include bleeding or hematoma at the access site, vessel injury, dissection, perforation, distal embolization, thrombosis, and need for additional treatment.
- MRI safety and conditional scanning requirements depend on the complete implanted or retained device configuration; the device labeling should be reviewed 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 Plus?
The TurboHawk Plus is indicated for use in patients with peripheral arterial disease requiring plaque excision to restore blood flow in affected arteries.
What outcomes have been reported in clinical studies?
Studies report the device's effectiveness in plaque removal and arterial patency improvement, though specific metrics are not detailed.
What complications have been reported?
Reported complications include arterial dissection and embolization, typical of 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.