Vascular Closure Devices

18 devices 13 with evidence

Clinical Overview

Vascular closure devices are used to achieve hemostasis after percutaneous vascular procedures, such as catheterizations. They address clinical challenges related to bleeding and access site complications, primarily benefiting patients undergoing diagnostic or interventional cardiovascular procedures. These devices are typically utilized by interventional radiologists, cardiologists, and vascular surgeons.
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Device Manufacturer Pathway Cleared Evidence
perclose vascular suture delivery device Evidence Abbott Vascular 510K 2000 20
perclose prostyle suture-mediated closure and repair system Evidence Abbott Vascular PMA 2021 20
angio-seal vascular closure device Evidence Terumo Medical PMA 2025 19
manta vascular closure device Evidence Teleflex Medical PMA 2020 14
starclose se r vascular surgical system Abbott Vascular Devices PMA 2025 2
starclose hex-hub dilator Evidence Abbott Vascular 510K 2007 2
starclose introducer set model- 1002 Abbott Vascular 510K 2006 2
cardiva vascade vascular closure system vcs Evidence Cardiva Medical PMA 2019 β€”
modification to vascular closure device Evidence Std Mfg. 510K 2001 β€”
x-press 6 french vascular closure system Evidence St. Jude Medical PMA 2003 β€”
vasostasis vascular closure system Cardiva Medical 510K 2004 β€”
cross-seal suture-mediated vascular closure device system Evidence Terumo Medical PMA 2023 β€”
exoseal r vascular closure device Cordis Us PMA 2026 β€”
mynx vascular closure device product family Cordis Us PMA 2014 β€”
vascular closure device Evidence Std Mfg. 510K 2000 β€”
celt acd vascular closure device Evidence Vasorum PMA 2017 β€”
boomerang closurewire vascular closure system Evidence Cardiva Medical 510K 2006 β€”
angiolink vascular closure system Evidence Medtronic Vascular PMA 2004 β€”

Evidence Landscape

The clinical evidence for vascular closure devices includes randomized controlled trials, registry data, and case series. Outcomes commonly measured are time to hemostasis, complication rates, and patient comfort. The strongest evidence supports the efficacy of suture-mediated and collagen plug-based devices, while evidence for newer technologies is still emerging.

Device Landscape

Vascular closure devices can be broadly categorized into suture-mediated devices, collagen plug-based devices, and clip-based systems. Key differentiating features include the mechanism of closure, such as mechanical suture, bioabsorbable plugs, or metallic clips, each offering distinct advantages in terms of deployment and hemostasis efficacy.

Clinical Workflow Considerations

Vascular closure devices are typically used in catheterization labs or interventional suites. Clinicians must consider device compatibility with the procedural sheath size and patient anatomy. Training often involves device-specific workshops and simulation-based learning to ensure proficiency in deployment techniques and complication management.

Frequently Asked Questions

What are vascular closure devices used for?

Vascular closure devices are used to achieve hemostasis at the access site following percutaneous vascular procedures, reducing bleeding complications and facilitating early ambulation.

What clinical evidence is available for vascular closure devices?

Clinical evidence includes randomized controlled trials, registries, and case series, focusing on outcomes like hemostasis time, complication rates, and patient satisfaction. Evidence quality varies, with robust data supporting established devices.

How do I choose between different vascular closure devices?

Clinicians consider factors such as patient-specific anatomy, procedural sheath size, and institutional protocols when selecting a vascular closure device.

What complications are associated with vascular closure devices?

Common complications include hematoma, infection, and arterial occlusion, while serious complications, though rare, can include vessel injury and device failure.

What training is required for vascular closure devices?

Training typically involves hands-on workshops and simulation exercises to develop proficiency in device deployment and management of potential complications.

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