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percutaneous greenfield vena cava filter system
Medi-Tech
Summary: The percutaneous Greenfield vena cava filter system is a device used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava. Key evidence highlights its efficacy in preventing recurrent embolisms with some reported complications.
FDA Clearance Information
Pathway 510K
Number K852097 ↗
Decision Date November 1, 1985
Product Code DTK
Device Class Class 2
Evidence 22 studies
The percutaneous Greenfield vena cava filter system was cleared by the FDA through the 510(k) pathway on November 1, 1985. It is manufactured by Medi-Tech and classified as a Class 2 device.
What It Is
The percutaneous Greenfield vena cava filter system is a medical device designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. It is used in patients at risk of thromboembolic events.
Clinical Applications
This device is commonly used in patients with a history of deep vein thrombosis or pulmonary embolism, particularly when anticoagulation therapy is contraindicated or has failed. It is also used prophylactically in high-risk surgical patients.
Evidence Summary
The available literature includes a mix of prospective and retrospective studies, case series, and experimental evaluations, with a total of 10 studies ranging from 1993 to 1999.
Reported Outcomes
Published studies report that the Greenfield filter effectively reduces the incidence of recurrent pulmonary embolism. In a study with 39 patients, only 2 cases of recurrent embolism were noted. The filter also demonstrated a high survival probability over a one-year follow-up.
Safety Profile
Reported complications include entrapment of guidewires during central venous catheter placement and instances of filter thrombosis. Some studies noted filter fragmentation and displacement, although the Greenfield filters generally remained intact.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to evaluate 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
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 percutaneous Greenfield vena cava filter system?
The device is indicated for patients at risk of thromboembolic events, particularly when anticoagulation is contraindicated or ineffective.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in recurrent pulmonary embolism and a high survival probability over a one-year follow-up.
What complications have been reported?
Complications reported include guidewire entrapment, filter thrombosis, and rare instances of filter fragmentation and displacement.
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.