Atherectomy Devices

103 devices 21 with evidence

Clinical Overview

Atherectomy devices are used to remove atherosclerotic plaque from blood vessels, addressing conditions such as peripheral artery disease and coronary artery disease. These devices are typically indicated for patients with significant vascular stenosis that is resistant to medical therapy. Interventional radiologists and vascular specialists commonly utilize these devices in minimally invasive procedures to restore blood flow.
Clear Filters
Device Manufacturer Pathway Cleared Evidence
auryon atherectomy catheter 1 5 mm xl hydrophilic coating exm-4010-h000 auryon atherectomy catheter 0 9 mm xl hydrophilic coating exm-4011-h000 auryon atherectomy catheter 1 5 mm xl exm -4010-0000 auryon atherectomy catheter 0 9 mm xl exm-4011-0000 Eximo Medical 510K 2023 419
auryon atherectomy catheter 1 7mm auryon atherectomy catheter 1 7mm hydrophilic coating Eximo Medical 510K 2024 419
modification to diamondback 360 degree orbital atherectomy system Evidence Cardio Systems 510K 2008 19
diamondback 360 orbital atherectomy system stealth 360 orbital pad system Evidence Cardiovascular Systems 510K 2011 19
diamondback 360 peripheral orbital atherectomy system Evidence Cardiovascular Systems 510K 2015 19
viperwire advance guide wire stealth 360 orbital peripheral atherectomy device pad diamondback 360 peripheral atherectomy system Cardiovascular Systems 510K 2018 19
diamondback 360 peripheral orbital atherectomy system exchangeable series Evidence Cardiovascular Systems 510K 2018 19
diamondback 360 peripheral orbital atherectomy system stealth 360 peripheral orbital atherectomy system Evidence Cardiovascular Systems 510K 2019 19
diamondback 360 degree orbital atherectomy system with viperslide lubricant Evidence Cardiovascular Systems 510K 2008 19
diamondback 360 degree orbital atherectomy system Evidence Cardiovascular Systems 510K 2007 19
diamondback 360 peripheral orbital atherectomy system diamondback 360 peripheral orbital atherectomy system exchangeable series stealth 360 peripheral orbital atherectomy system Evidence Cardiovascular Systems 510K 2022 19
diamondback 360 degree orbital atherectomy system Evidence Cardiovascular Systems 510K 2007 19
diamondback 360 peripheral orbital atherectomy system stealth 360 peripheral orbital atherectomy system diamondback 360 peripheral orbital atherectomy system exchangeable series Evidence Cardiovascualr Systems 510K 2022 19
diamondback 360 peripheral orbital atherectomy system Evidence Cardiovascular Systems 510K 2013 19
diamondback spinal system Eminent Spine 510K 2010 19
diamondback 360 dbx Cardiovascular Systems 510K 2009 19
diamondback 360 coronary orbital atherectomy device oad orbital atherectomy system pump oas pump viperwire advance c Evidence Cardiovascular Systems PMA 2019 19
diamondback 360 degree orbital atherectomy system for treatment of a-v shunt stenosis Evidence Cardiovascular Systems 510K 2007 19
diamonback 360 peripheral orbital atherectomy system diamondback 360 stealth orbital atherectomy system Evidence Cardiovascular Systems 510K 2021 19
diamondback 360 peripheral orbital atherectomy system diamondback 360 peripheral orbital atherectomy system exchangeable series stealth 360 peripheral orbital atherectomy system Evidence Cardiovascular Systems 510K 2020 19
viperwire advance guide wire diamondback 360 peripheral orbital atherectomy system stealth 360 orbital pad Cardiovascular System 510K 2015 19
modification to diamondback 360 orbital atherectomy system Evidence Cardiovascular Systems 510K 2007 19
diamondback 360 peripheral orbital atherectomy system Evidence Cardiovascular Systems 510K 2017 19
diamondback 360 peripheral orbital atherectomy system Evidence Cardiovascular Systems 510K 2014 19
diamondback 360 peripheral orbital atherectomy system Evidence Cardiovascular Systems 510K 2015 19
jetstream navitus l system jeystream navitus system jetstream g3 sf system jetstream sf 1 6 system Medrad 510K 2012 18
jetstream g3 system model pv31300 pv console model pvcn100 Pathway Medical Technologies 510K 2010 18
jetstream xc 2 4 3 4 system jetstream xc 2 1 3 0 system jetstream sc 1 85 system jetstream sc 1 6 system Medrad 510K 2013 18
jetstream pathway pv atherectomy system model pv10300 pvcn100 Pathway Medical Technologies 510K 2008 18
jetstream Evidence Deldent 510K 2002 18
jetstream g3 l system model pv31400 jetstream g3 l catheter with control pod pvcn100 pv console Pathway Medical Technologies 510K 2010 18
jetstream g3 se system jetstream g3 sf system model pv31230 jetstream g3 se catheter and control pod pvcn100 pv con Pathway Medical Technologies 510K 2010 18
jetstream g3 l system pv console models pv31400 pv31300 pvcn100 Pathway Medical Technologies 510K 2010 18
jetstream g2 system models pv20300 jetstream g2 catheter and control pod pvcn100 pv console Pathway Medical Technologies 510K 2009 18
jetstream cavity preparation system Dove Systems 510K 1996 18
jetstream g3 system model pv31300 jetstream g3 catheter and control pod pvcn100 pv console Pathway Medical Technologies 510K 2009 18
jetstream pathway pc atherectomy system model ov10300 Pathway Medical Technologies 510K 2009 18
ensphere tempo jetstream workspace cardiology module Adac Laboratories 510K 2004 18
jetstream navitus system jetstream g3 sf system jetstream g3 se system jetstream g3 l system Pathway Medical Technologies 510K 2011 18
jetstream g2 nxt system model pv20300 Pathway Medical Technologies 510K 2009 18
jetstream xc 2 4 3 4 jetstream xc 2 1 3 0 jetstream sc 1 85 jetstream sc 1 6 Medrad 510K 2014 18
jetstream g3 r sf 1 6 system Pathway Medical Technologies 510K 2011 18
jetstream workspace Adac Laboratories 510K 2004 18
jetstream navitus l system Pathway Medical Technologies 510K 2012 18
jetstream g2 system models pv20300 jetstream g2 catheter and control pod pvcn100 pv console Pathway Medical Technologies 510K 2009 18
jetstream g3 system Pathway Medical Technologies 510K 2009 18
jetstream workspace Adac Laboratories 510K 2006 18
1 8mm x 149cm phoenix atherectomy system 2 2mm x 149cm phoenix atherectomy system 2 4mm x 130cm phoenix atherectomy system Volcano Atheromed 510K 2017 8
phoenix 5f tracking atherectomy catheter phoenix 6f tracking atherectomy catheter phoenix 7d deflecting atherectomy ca Atheromed 510K 2014 8
1 8mm x 149 cm phoenix atherectomy catheter 2 2mm x 149 cm phoenix atherectomy catheter phoenix handle phoenix wire support clip Evidence Volcano Atheromed 510K 2014 8

Evidence Landscape

The clinical evidence for atherectomy devices includes randomized controlled trials (RCTs), registry data, and case series. Outcomes typically measured include procedural success, restenosis rates, and complication rates. Evidence is strongest for certain devices in specific indications, though there are gaps in long-term outcome data.

Device Landscape

Atherectomy devices can be categorized into several subtypes, including directional, rotational, orbital, and laser atherectomy systems. Each type has unique mechanisms of action, such as cutting, sanding, or vaporizing plaque, which differentiates them based on the specific clinical scenarios they are best suited for.

Clinical Workflow Considerations

Atherectomy procedures are typically performed in catheterization labs or hybrid operating rooms. Clinicians should be trained in device-specific techniques and aware of setup requirements. Decision points often include device selection based on lesion characteristics and patient-specific factors.

Frequently Asked Questions

What are atherectomy devices used for?

Atherectomy devices are primarily used to remove plaque from blood vessels in patients with peripheral artery disease or coronary artery disease, improving blood flow and reducing symptoms.

What clinical evidence is available for atherectomy devices?

The evidence includes RCTs, registries, and case series, focusing on outcomes like procedural success and restenosis rates. Evidence quality varies, with some devices having robust data in specific indications.

How do I choose between different atherectomy devices?

Clinicians consider patient-specific factors, lesion characteristics, and institutional resources when choosing between devices. Each device type has unique features suited to different clinical scenarios.

What complications are associated with atherectomy devices?

Common complications include vessel dissection and embolization, while serious complications can include perforation and thrombosis. The safety profile varies by device and patient condition.

What training is required for atherectomy devices?

Training typically involves device-specific workshops, hands-on practice, and competency assessments to ensure safe and effective use of the devices.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.