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Stainless Steel Greenfield Vena Cava Filter with 12f Flexcarrier Introducter System
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 effectiveness in embolus capture and potential complications observed in follow-up imaging.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K955396 ↗
Decision Date ?
February 9, 1996
Product Code ?
DTK Filter, Intravascular, Cardiovascular
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 February 9, 1996. It is manufactured by Boston Scientific and classified as a Class 2 medical 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 typically used in patients who cannot undergo anticoagulation therapy.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for venous thromboembolism.
- Use when anticoagulant therapy is contraindicated.
- Use when pulmonary embolism occurs despite anticoagulant therapy or anticoagulation is ineffective.
Clinical Applications
- Placement in the inferior vena cava for patients at risk of pulmonary embolism who cannot receive anticoagulants.
- Placement for patients with venous thromboembolism when anticoagulant therapy is ineffective.
- Use as mechanical protection against embolization of thrombi from the lower-extremity or pelvic veins to the pulmonary arteries.
Reported off-label uses
- Use for selected patients with recurrent pulmonary embolism despite adequate anticoagulation, when clinicians determine that additional mechanical protection is appropriate.
- Use in selected trauma or surgical patients considered at exceptionally high risk for venous thromboembolism when standard prophylaxis cannot be used.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 10 studies ranging from 1997 to 2020, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies evaluate the device'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. Studies also highlight its performance in different anatomical placements, such as suprarenal IVC, and compare its efficacy with other filter designs.
Safety Profile
Reported complications include filter tilt, asymmetry, and insertion issues, as well as potential complications observed in follow-up CT imaging. Some studies have also evaluated the effects of gravitational force on the filter's performance.
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 assess long-term outcomes and compare the efficacy of different filter designs.
Practical Considerations
- The device is delivered through a 12 French FlexCarrier introducer system; venous access and vessel size must accommodate the delivery system.
- Placement is usually performed under fluoroscopic or other imaging guidance through venous access, commonly in the femoral or internal jugular vein.
- The filter is a permanent stainless steel device; retrieval should not be assumed unless the specific device labeling and clinical circumstances support it.
- MRI compatibility should be confirmed from the applicable Boston Scientific labeling and institutional MRI safety procedures before scanning.
- Potential complications include filter migration, tilt, penetration, thrombosis or occlusion of the inferior vena cava, access-site bleeding, and recurrent pulmonary embolism.
Procedures that use this device
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
View Source →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
View Source →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 device is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy or in whom anticoagulation is ineffective.
What outcomes have been reported in clinical studies?
Studies report effective embolus capture and reduced risk of pulmonary embolism, with performance varying based on anatomical placement and filter design.
What complications have been reported?
Safety data indicate complications such as filter tilt, asymmetry, insertion issues, and potential adverse effects observed in follow-up imaging.
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.