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modification to silverhawk peripheral plaque excision system models 02550 04800 05200 06002 02406 04706 04300
Fox Hollow Technologies
Summary: The SilverHawk Peripheral Plaque Excision System is a medical device used for atherectomy, primarily in peripheral artery disease. It is utilized by vascular specialists to remove plaque from blood vessels in the lower extremities.
FDA Clearance Information
Pathway
510K
Number
K053460 ↗
Decision Date
January 13, 2006
Product Code
MCW
Device Class
Class 2
Evidence
7 studies
The SilverHawk Peripheral Plaque Excision System was cleared through the FDA 510(k) pathway on January 13, 2006. Manufactured by Fox Hollow Technologies, it is classified as a Class 2 medical device under product code MCW.
What It Is
The SilverHawk Peripheral Plaque Excision System is an atherectomy device designed to remove plaque from peripheral arteries. It operates by cutting and collecting atherosclerotic plaque, thereby restoring blood flow in occluded vessels. This device is particularly useful in treating peripheral artery disease, a common condition in which arteries in the legs become narrowed or blocked.
Clinical Applications
This device is commonly used in vascular surgery and interventional cardiology, particularly for patients with peripheral artery disease affecting the lower extremities. It is often employed in hospital settings, outpatient surgical centers, and specialized vascular clinics. Patients who benefit from this procedure typically have symptoms such as claudication or critical limb ischemia.
Indications for Use
The FDA indications for the SilverHawk system include the removal of plaque from peripheral arteries, particularly in patients with peripheral artery disease. It is intended for use in patients who have significant arterial blockages that may lead to reduced blood flow and associated symptoms.
Practical Considerations
The device comes in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of patient anatomies. Clinicians should be familiar with the technique of atherectomy and consider factors such as vessel size and plaque characteristics when selecting the appropriate model.
Related Literature
The DEFINITIVE™ LE study investigated the use of the SilverHawk and TurboHawk devices in treating lower extremity vessels. Although the abstract is not available, such studies typically assess the safety and efficacy of the device in real-world clinical settings. Limitations may include the lack of long-term follow-up data and potential selection bias in patient populations.
Linked Studies (7)
PubMed • 2009
Use and abuse of atherectomy: where should it be used?
Seminars in vascular surgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2009
Atherectomy for infrainguinal peripheral artery disease.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
View Source →
PubMed • 2007
Infrainguinal arterial intervention: is there a role for an atherectomy device?
Vascular
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2007
Treatment of an Angio-Seal-related vascular complication using the SilverHawk plaque excision system: a case report.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2006
Plaque excision for the treatment of infrainguinal arterial occlusive disease.
Techniques in vascular and interventional radiology
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 SilverHawk Peripheral Plaque Excision System used for?
It is used for removing plaque from peripheral arteries, particularly in patients with peripheral artery disease.
What specialties typically use this device?
Vascular surgery and interventional cardiology specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of plaque from peripheral arteries in patients with peripheral artery 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.