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titanium greenfield vena cava filter carrier
Medi-Tech
Summary: The titanium Greenfield vena cava filter by Medi-Tech is used to prevent pulmonary embolism. It is FDA 510k cleared and has been studied in clinical settings, showing successful insertion and no reported complications in initial studies.
FDA Clearance Information
Pathway 510K
Number K874096 ↗
Decision Date November 4, 1988
Product Code DTK
Device Class Class 2
Evidence 22 studies
The titanium Greenfield vena cava filter was cleared by the FDA through the 510k pathway on November 4, 1988. Manufactured by Medi-Tech, it is classified as a Class 2 medical device.
What It Is
The titanium Greenfield vena cava filter is a medical device designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is intended for percutaneous insertion and is used in patients with contraindications to anticoagulation therapy.
Clinical Applications
Commonly used in patients with deep venous thrombosis who cannot receive anticoagulation therapy, the titanium Greenfield filter is deployed in the inferior vena cava to prevent clots from reaching the lungs.
Evidence Summary
The available literature includes two studies, a case series and an unknown type, published between 1995 and 1996. These studies focus on the initial experience and retrieval of the titanium Greenfield filter.
Reported Outcomes
Published studies report successful percutaneous insertion of the titanium Greenfield vena cava filter in all patients studied, with no complications or filter migration observed. The device demonstrated efficacy in preventing pulmonary embolism in patients with contraindications to anticoagulation.
Safety Profile
Reported complications include no instances of bruising, hematoma, or bleeding in the studied cases. The initial experience suggests a low complication rate for the titanium Greenfield filter.
Evidence Limitations
The evidence is limited to a small number of studies with a small sample size. Further research is needed to assess long-term outcomes and safety in a larger, more diverse patient population.
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 titanium Greenfield vena cava filter?
The device is indicated for patients at risk of pulmonary embolism who have contraindications to anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report successful insertion and no complications or filter migration in patients.
What complications have been reported?
No complications such as bruising, hematoma, or bleeding were reported in the studies.
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.