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sentry ivc filter
Novate Medical
Summary: The Sentry IVC Filter by Novate Medical is a bioconvertible device designed for temporary protection against pulmonary embolism. Key evidence includes studies on its safety and effectiveness, with a focus on its bioconversion feature.
FDA Clearance Information
Pathway
510K
Number
K173236 ↗
Decision Date
February 22, 2018
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Sentry IVC Filter received FDA clearance through the 510(k) pathway on February 22, 2018. It is manufactured by Novate Medical and classified as a Class 2 medical device.
What It Is
The Sentry IVC Filter is a bioconvertible device intended to provide temporary protection from pulmonary embolism by capturing emboli in the inferior vena cava. It is designed to bioconvert and become incorporated into the vessel wall, maintaining a patent IVC lumen.
Clinical Applications
The Sentry IVC Filter is commonly used in patients who require temporary protection from pulmonary embolism, particularly in scenarios where anticoagulation therapy is contraindicated or ineffective.
Evidence Summary
The available literature includes five studies, comprising randomized controlled trials and prospective analyses, conducted between 2019 and 2020. These studies evaluate the safety and effectiveness of the Sentry IVC Filter in clinical and experimental settings.
Reported Outcomes
Published studies report that the Sentry IVC Filter effectively provides temporary protection against pulmonary embolism, with successful bioconversion observed in clinical trials. The device demonstrated a high rate of incorporation into the vessel wall, maintaining IVC patency.
Safety Profile
Reported complications include device migration and filter fracture, although these events were infrequent. Overall, the Sentry IVC Filter was associated with a favorable safety profile in the studies reviewed.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and short follow-up durations in some studies. Further research is needed to assess long-term outcomes and rare adverse events associated with the Sentry IVC Filter.
Frequently Asked Questions
What are the clinical indications for Sentry IVC Filter?
The Sentry IVC Filter is indicated for temporary protection against pulmonary embolism in patients where anticoagulation is contraindicated or ineffective.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective temporary protection against pulmonary embolism and successful bioconversion with maintained IVC patency.
What complications have been reported?
Reported complications include device migration and filter fracture, though these were infrequent in the reviewed 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.