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silverhawk peripheral plaque excision system turbohawk peripheral plaque excision system
Medtronic Vascular
Summary: The SilverHawk and TurboHawk are atherectomy devices used for plaque excision in peripheral arteries. They are primarily used in patients with peripheral artery disease (PAD). Key evidence highlights their role in reducing restenosis rates compared to traditional angioplasty.
FDA Clearance Information
Pathway
510K
Number
K170191 ↗
Decision Date
June 16, 2017
Product Code
MCW
Device Class
Class 2
Evidence
7 studies
The SilverHawk and TurboHawk systems were cleared by the FDA via the 510(k) pathway on June 16, 2017. Manufactured by Medtronic Vascular, these devices are classified as Class 2 under product code MCW.
What It Is
The SilverHawk and TurboHawk are directional atherectomy devices designed to excise atheromatous plaque from peripheral arteries. They are used to treat peripheral artery disease by removing plaque and restoring blood flow, thereby reducing the risk of restenosis.
Clinical Applications
These devices are commonly used in patients with peripheral artery disease, particularly in infrainguinal arteries. They are employed in scenarios where plaque excision is necessary to improve blood flow and alleviate symptoms such as 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 efficacy and safety of directional atherectomy in peripheral artery disease.
Reported Outcomes
Published studies report that the use of SilverHawk and TurboHawk devices in directional atherectomy can effectively reduce restenosis rates compared to conventional angioplasty. The DEFINITIVE LE study highlighted their safety and effectiveness in treating infrainguinal arteries. Other studies suggest potential benefits when combined with drug-eluting balloon angioplasty.
Safety Profile
Reported complications include vascular injury and restenosis, although these are less frequent compared to traditional angioplasty. The devices have been associated with a favorable safety profile in the treatment of peripheral artery disease.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up data and the relatively small sample sizes in some studies. Further research is needed to establish the long-term efficacy and safety of these devices, particularly in diverse 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 are the clinical indications for SilverHawk and TurboHawk?
These devices are 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 reduced restenosis rates and improved blood flow in treated arteries, with a favorable safety profile.
What complications have been reported?
Reported complications include vascular injury and restenosis, though these are less frequent compared to traditional angioplasty.
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.