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silverhawk peripheral plaque excision system models 02550 04800 05200 02406 04706 04300
Fox Hollow Technologies
Summary: The SilverHawk Peripheral Plaque Excision System is a catheter-based device used for the excision of atheromatous plaque in peripheral arteries. It is primarily used in patients with peripheral artery disease (PAD) to improve blood flow. Key evidence suggests its effectiveness in reducing plaque burden.
FDA Clearance Information
Pathway
510K
Number
K043553 ↗
Decision Date
February 18, 2005
Product Code
MCW
Device Class
Class 2
Evidence
7 studies
The SilverHawk Peripheral Plaque Excision System was cleared by the FDA via the 510(k) pathway on February 18, 2005. It is manufactured by Fox Hollow Technologies and classified as a Class 2 medical device.
What It Is
The SilverHawk Peripheral Plaque Excision System is a directional atherectomy device designed to remove atheromatous plaque from peripheral arteries. It is used to treat peripheral artery disease by improving blood flow and reducing arterial blockages.
Clinical Applications
Commonly used in patients with peripheral artery disease, the SilverHawk device is applied in scenarios where plaque excision is necessary to restore adequate blood flow, particularly in infrainguinal arteries. It is often considered in cases of claudication or critical limb ischemia.
Evidence Summary
The available literature includes a mix of randomized controlled trials, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2007 to 2016, focusing on the device's efficacy and safety in treating peripheral artery disease.
Reported Outcomes
Published studies report that the SilverHawk device effectively reduces plaque burden and improves blood flow in peripheral arteries. The DEFINITIVE LE study demonstrated its safety and effectiveness over a 12-month period. Other studies highlight its potential when combined with drug-eluting balloon angioplasty for enhanced outcomes.
Safety Profile
Reported complications include potential vascular injuries and restenosis, although the device is generally considered safe. Some studies noted the risk of arterial wall damage, which is a concern with any atherectomy procedure.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up data and the variability in study designs. Further research is needed to compare the SilverHawk device directly with other atherectomy devices and to evaluate its long-term efficacy and safety.
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 are the clinical indications for the SilverHawk Peripheral Plaque Excision System?
The device is indicated for the excision of atheromatous plaque in patients with peripheral artery disease, particularly in infrainguinal arteries.
What outcomes have been reported in clinical studies?
Studies report effective plaque reduction and improved blood flow, with the DEFINITIVE LE study showing positive 12-month results.
What complications have been reported?
Reported complications include vascular injuries and restenosis, with some risk of arterial wall damage noted in studies.
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.