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turbohawk peripheral plaque excision system
Ev3
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
510K
Number
K093301 ↗
Decision Date
November 6, 2009
Product Code
MCW
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.
Clinical Applications
This device is commonly used in clinical settings for patients with PAD, particularly those with femoral and popliteal artery lesions. It is often employed in conjunction with other interventions, such as drug-coated balloon angioplasty, to enhance treatment outcomes.
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.
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.