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safeflo vena cava filter
Rmt Medical Technilogies
Summary: The SafeFlo Vena Cava Filter is a retrievable device designed to prevent pulmonary embolism by trapping blood clots in the inferior vena cava. Key evidence includes in vitro evaluation of clot-trapping ability and a pivotal safety and effectiveness study.
FDA Clearance Information
Pathway
510K
Number
K081138 ↗
Decision Date
May 7, 2009
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The SafeFlo Vena Cava Filter was cleared through the FDA 510(k) pathway on May 7, 2009. It is manufactured by Rmt Medical Technologies and classified as a Class 2 device under product code DTK.
What It Is
The SafeFlo Vena Cava Filter is a retrievable device made from nitinol, designed to capture blood clots in the inferior vena cava to prevent pulmonary embolism. It is intended for temporary or permanent placement in patients at risk of thromboembolic events.
Clinical Applications
Commonly used in patients with contraindications to anticoagulation therapy, those with recurrent venous thromboembolism despite anticoagulation, or as a prophylactic measure in high-risk surgical patients.
Evidence Summary
The available literature includes an in vitro study evaluating the device's clot-trapping ability and a pivotal clinical trial assessing its safety and effectiveness. The studies span from 2003 to an unspecified date.
Reported Outcomes
Published studies report that the SafeFlo Vena Cava Filter effectively traps clots in an in vitro model, demonstrating stability and minimal migration. However, specific clinical outcomes from the pivotal study are not detailed in the provided evidence.
Safety Profile
Reported complications include potential device migration and filter fracture, as suggested by the in vitro evaluation. The pivotal study's safety data is not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data from the pivotal study. Further research is needed to assess long-term clinical outcomes and complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for SafeFlo Vena Cava Filter?
The SafeFlo Vena Cava Filter is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy or have recurrent thromboembolism despite treatment.
What outcomes have been reported in clinical studies?
In vitro studies report effective clot-trapping and minimal migration, but specific clinical outcomes from the pivotal study are not detailed.
What complications have been reported?
Reported complications include potential device migration and filter fracture, based on in vitro evaluations.
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.