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Turbohawk Peropheral Plaque Excision System
Product: TurboHawk — all models and sizes
Summary: The TurboHawk Peripheral Plaque Excision System is a medical device used for atherectomy, a procedure to remove plaque from blood vessels. It is primarily used by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K103618 ↗
Decision Date ?
January 5, 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 via the 510(k) pathway on January 5, 2011. Manufactured by Ev3, it is classified as a Class 2 device under product code MCW.
What It Is
The TurboHawk Peripheral Plaque Excision System is an atherectomy device designed to remove atherosclerotic plaque from peripheral arteries. It operates by cutting and collecting plaque using a rotating blade housed within a catheter. This device is particularly useful in treating peripheral arterial disease (PAD) by restoring blood flow and reducing symptoms such as claudication.
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries.
- Treatment of obstructive peripheral arterial disease when plaque is impairing blood flow.
- Use in peripheral arterial vessels appropriate for the labeled catheter size and device design.
Clinical Applications
- Directional atherectomy of plaque in lower-extremity peripheral arteries.
- Treatment of peripheral arterial lesions causing reduced blood flow or intermittent claudication.
- Plaque removal before or instead of adjunctive balloon angioplasty when clinically appropriate.
- Endovascular treatment of selected peripheral arterial blockages using fluoroscopic guidance.
Practical Considerations
- The system is available in multiple catheter configurations and sizes; the selected device must match the target vessel diameter and lesion anatomy.
- The device is advanced over a compatible guidewire and operated under fluoroscopic imaging by clinicians trained in peripheral atherectomy.
- Atherectomy may be combined with balloon angioplasty, stenting, or medication-based treatment depending on the lesion and blood-flow result.
- Patients with unsuitable vessel anatomy, severe calcification, thrombosis, dissection, or other contraindications may require an alternative treatment; the specific labeling should be reviewed before use.
- MRI safety depends on the individual device components and whether the system remains in the patient. The current manufacturer labeling should be checked; an unused or removed catheter should not be assumed to be MRI relevant.
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 is the TurboHawk Peripheral Plaque Excision System used for?
It is used for removing plaque from peripheral arteries to treat peripheral arterial disease.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of plaque from peripheral arteries to improve blood flow in patients with peripheral arterial disease.
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.