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Silverhawk Peripheral Plaque Excision System
Foxhollow Technologies
Product: SilverHawkTM — all models and sizes
Summary: The SilverHawk Peripheral Plaque Excision System is a catheter-based device used for atherectomy in peripheral artery disease. It is primarily used to remove atheromatous plaque from peripheral arteries. Key evidence highlights its use in combination with other treatments for improved outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K061188 ↗
Decision Date ?
October 23, 2006
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
7 studies
The SilverHawk Peripheral Plaque Excision System was cleared by the FDA via the 510(k) pathway on October 23, 2006. Manufactured by Foxhollow Technologies, it is classified as a Class 2 medical device.
What It Is
The SilverHawk Peripheral Plaque Excision System is a catheter-based atherectomy device designed to excise atheromatous plaque from peripheral arteries. It is intended for use in patients with peripheral artery disease to improve blood flow by removing plaque.
FDA-Cleared Indications
- Excision of atheromatous plaque from peripheral arteries in patients with peripheral artery disease.
- Use in peripheral arteries that are appropriate for the device size and configuration.
- Treatment intended to improve arterial lumen patency and blood flow.
Clinical Applications
- Directional atherectomy of atherosclerotic plaque in peripheral lower-extremity arteries.
- Plaque removal as part of an endovascular procedure for peripheral artery disease.
- Lesion preparation before or in combination with other peripheral interventions when clinically indicated.
- Treatment of peripheral arterial stenotic disease when plaque excision is appropriate for the vessel anatomy.
Evidence Summary
The available literature includes a mix of RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. These studies span from 2007 to 2016, focusing on the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the SilverHawk system is effective in improving arterial patency and reducing symptoms in patients with peripheral artery disease. Some studies highlight its use in combination with drug-eluting balloon angioplasty for enhanced outcomes. However, long-term benefits over traditional angioplasty remain inconclusive.
Safety Profile
Reported complications include vascular injury and restenosis, which are common concerns with atherectomy devices. Some studies note the potential for device-related complications, but overall safety profiles are consistent with other endovascular interventions.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up data and small sample sizes in some studies. Further research is needed to establish the long-term efficacy and safety of the SilverHawk system compared to other treatment modalities.
Practical Considerations
- The system is available in different catheter configurations and sizes; selection depends on vessel diameter, lesion characteristics and access anatomy.
- The device is advanced over a guidewire through vascular access, commonly from the common femoral artery, under fluoroscopic imaging.
- Atherectomy may be followed by balloon angioplasty, stent placement or another treatment if residual stenosis or vessel recoil remains.
- Contraindications and precautions include unsuitable vessel size, severe tortuosity, heavily calcified or otherwise difficult anatomy, thrombus and inability to safely cross the lesion; the official labeling should be reviewed before use.
- MRI compatibility depends on the specific device and whether it remains in the patient. The device is generally removed after the procedure, and the current labeling should be checked for MRI conditions.
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 SilverHawk Peripheral Plaque Excision System?
The device is indicated for the excision of atheromatous plaque in patients with peripheral artery disease to improve blood flow.
What outcomes have been reported in clinical studies?
Studies report improved arterial patency and symptom relief, particularly when used with adjunctive therapies like drug-eluting balloons.
What complications have been reported?
Safety data indicate potential complications such as vascular injury and restenosis, consistent with other atherectomy devices.
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.