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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 highlights its safety and effectiveness over a two-year period.
FDA Clearance Information
Pathway
510K
Number
K162875 ↗
Decision Date
February 17, 2017
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Sentry IVC Filter received FDA 510(k) clearance on February 17, 2017. Manufactured by Novate Medical, it is classified as a Class 2 device under product code DTK.
What It Is
The Sentry IVC Filter is a bioconvertible device intended for temporary protection against pulmonary embolism. It is designed to be implanted in the inferior vena cava and later incorporate into the vessel wall, maintaining a patent lumen.
Clinical Applications
The Sentry IVC Filter is commonly used in clinical scenarios requiring temporary protection from pulmonary embolism, such as in patients with contraindications to anticoagulation or those undergoing high-risk surgical procedures.
Evidence Summary
The available literature includes five studies, comprising prospective and retrospective 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 provides effective temporary protection against pulmonary embolism, with successful bioconversion and incorporation into the vessel wall observed in clinical and experimental settings. The device demonstrated favorable outcomes over a two-year follow-up period.
Safety Profile
Reported complications include the potential for device migration and incorporation issues, though these were infrequent. Overall, the safety profile of the Sentry IVC Filter is considered acceptable based on the available evidence.
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.
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 with contraindications to anticoagulation or those undergoing high-risk procedures.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective temporary protection against pulmonary embolism and successful bioconversion of the device with favorable outcomes over two years.
What complications have been reported?
Safety data from evidence indicate potential complications such as device migration and incorporation issues, though these are infrequent.
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.