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turbohawk peropheral plaque excision system
Ev3
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
510K
Number
K103618 ↗
Decision Date
January 5, 2011
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 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.
Clinical Applications
This device is commonly used in the treatment of peripheral arterial disease, particularly in the lower extremities. Vascular surgeons and interventional radiologists use it in hospital and outpatient settings to improve blood flow in patients with significant arterial blockages. It is suitable for patients who are not ideal candidates for more invasive surgical procedures.
Indications for Use
The FDA indications for the TurboHawk system include the removal of plaque from peripheral arteries to treat conditions like peripheral arterial disease. It is intended for patients with significant arterial blockages that impair blood flow.
Practical Considerations
The TurboHawk system comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires fluoroscopic guidance for precise placement and operation. Clinicians should be trained in atherectomy techniques to optimize outcomes.
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.