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modification to silverhawk peripheral plaque excision system models p4028 fg08300
Foxhollow Technologies
Summary: The SilverHawk 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 in the treatment of peripheral artery disease.
FDA Clearance Information
Pathway
510K
Number
K061063 ↗
Decision Date
May 18, 2006
Product Code
MCW
Device Class
Class 2
Evidence
7 studies
The SilverHawk Peripheral Plaque Excision System received FDA clearance through the 510(k) pathway on May 18, 2006. Manufactured by Foxhollow Technologies, it is classified as a Class 2 medical device.
What It Is
The SilverHawk Peripheral Plaque Excision System is an atherectomy device designed to remove atherosclerotic plaque from peripheral arteries. It works by cutting and collecting plaque from the vessel wall, which helps restore blood flow. This device is particularly useful in treating peripheral artery disease (PAD), a condition characterized by narrowed arteries in the legs and feet.
Clinical Applications
This device is commonly used in the treatment of peripheral artery disease, particularly in patients with significant plaque buildup in the lower extremities. Vascular surgeons and interventional radiologists typically use it in hospital settings or specialized outpatient centers. It is suitable for patients who are symptomatic with claudication or have critical limb ischemia.
Indications for Use
The FDA-cleared indications for this device include the removal of plaque from peripheral arteries, which is beneficial for patients with peripheral artery disease. It is used to improve blood flow and alleviate symptoms such as leg pain and cramps during walking.
Practical Considerations
The SilverHawk system is available in various sizes to accommodate different vessel diameters. It is important to select the appropriate size for the target vessel to ensure effective plaque removal. The device is compatible with standard guidewires and catheters used in peripheral interventions.
Related Literature
The DEFINITIVE™ LE study investigated the use of the SilverHawk and TurboHawk devices in treating lower extremity vessels affected by peripheral artery disease. While specific findings are not detailed, such studies typically assess the safety and efficacy of the device in improving blood flow and reducing symptoms. Limitations may include the study's design and patient selection criteria.
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 to treat peripheral artery 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 cleared for the removal of plaque from peripheral arteries to improve blood flow 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.