📊 Evidence-Based Reference

stainless steel greenfield vena cava filter with 24f introducer system

Boston Scientific

Summary: The stainless steel Greenfield vena cava filter by Boston Scientific is used to prevent pulmonary embolism in patients with contraindications to anticoagulation. Key evidence highlights its efficacy in embolus capture and associated complications.

FDA Clearance Information

Pathway 510K
Decision Date June 22, 1995
Product Code DTK
Device Class Class 2
Evidence 22 studies

The stainless steel Greenfield vena cava filter was cleared by the FDA via the 510(k) pathway on June 22, 1995. It is manufactured by Boston Scientific and classified as a Class 2 device.

What It Is

The stainless steel Greenfield vena cava filter is a medical device designed to prevent pulmonary embolism by capturing emboli in the inferior vena cava. It is intended for patients who cannot undergo anticoagulation therapy.

Clinical Applications

This device is commonly used in patients with deep vein thrombosis who are at risk of pulmonary embolism and have contraindications to anticoagulation. It is also used in scenarios where anticoagulation is ineffective or not tolerated.

Evidence Summary

The available literature includes 10 studies, ranging from 1997 to 2020, encompassing various study types such as RCTs and retrospective analyses. These studies evaluate the filter's hemodynamics, placement outcomes, and complications.

Reported Outcomes

Published studies report that the Greenfield vena cava filter effectively captures emboli, reducing the risk of pulmonary embolism. The filter's design has been analyzed for its hemodynamic properties and embolus capture efficiency. Clinical outcomes for suprarenal placements have also been documented.

Safety Profile

Reported complications include filter tilt, asymmetry, and insertion issues. Studies have also evaluated the effects of gravitational forces on the filter, noting potential risks associated with acceleration stress.

Evidence Limitations

The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and compare the efficacy of different filter designs.

Linked Studies (20)

PubMed • 2020

Greenfield stainless steel vena cava filters on computed tomography follow-up.

Journal of vascular surgery. Venous and lymphatic disorders

Other View Source →
PubMed • 2006

Numerical analysis of the hemodynamics and embolus capture of a greenfield vena cava filter.

Journal of biomechanical engineering

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2004

In vivo evaluation of the effects of gravitational force (+Gz) on over-the-wire stainless steel Greenfield inferior vena cava filter in swine.

Cardiovascular and interventional radiology

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PubMed • 1999

Entrapment of J-tip guidewires by Venatech and stainless-steel Greenfield vena cava filters during central venous catheter placement: percutaneous management in four patients.

Cardiovascular and interventional radiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1998

IVC filter tilt and asymmetry: comparison of the over-the-wire stainless-steel and titanium Greenfield IVC filters.

Journal of vascular and interventional radiology : JVIR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1998

Suprarenal filter placement.

Journal of vascular surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1997

Evaluation of a new percutaneous stainless steel Greenfield filter.

Journal of vascular and interventional radiology : JVIR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1996

Successful retrieval of a titanium Greenfield vena cava filter embedded within its introducer sheath.

Journal of vascular and interventional radiology : JVIR

View Source →
PubMed • 1996

Caval interruption methods: comparison of options.

Seminars in vascular surgery

View Source →
PubMed • 1995

The new titanium Greenfield vena cava filter: initial experience and review.

Singapore medical journal

Case Series View Source →
PubMed • 1995

[Partial interruption of the inferior vena cava using a Greenfield titanium percutaneous filter. Present indications and evaluation].

Journal des maladies vasculaires

Prospective View Source →
PubMed • 1994

Management of deep vein thrombosis of the lower extremity in pregnancy.

The West Virginia medical journal

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1993

New retrievable percutaneous vena cava filter: experimental in vitro and in vivo evaluation.

Cardiovascular and interventional radiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1992

LGM vena cava filter: objective evaluation of early results.

Journal of vascular and interventional radiology : JVIR

View Source →
PubMed • 1990

Perforation of the inferior vena cava by a suprarenal Greenfield filter.

Radiology

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PubMed • 1990

Percutaneous inferior vena caval filters.

Radiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1989

Comparison of titanium and stainless steel, Greenfield vena caval filters.

Surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1987

Percutaneous transfemoral placement of the Kimray-Greenfield vena cava filter.

Radiology

View Source →
PubMed • 1987

Experimental comparison of percutaneous vena caval devices: titanium Greenfield filter versus bird's nest filter.

Journal of vascular surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 1986

Percutaneous Kimray-Greenfield filter placement.

AJR. American journal of roentgenology

View Source →

Frequently Asked Questions

What are the clinical indications for the stainless steel Greenfield vena cava filter?

The filter is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy.

What outcomes have been reported in clinical studies?

Studies report effective embolus capture and reduced risk of pulmonary embolism, with evaluations of hemodynamic properties and placement outcomes.

What complications have been reported?

Safety data indicate complications such as filter tilt, asymmetry, and insertion issues, with risks associated with gravitational forces.

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.

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