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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
K181202 ↗
Decision Date
June 6, 2018
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Sentry IVC Filter was cleared by the FDA via the 510(k) pathway on June 6, 2018. It is manufactured by Novate Medical and classified as a Class 2 device.
What It Is
The Sentry IVC Filter is a bioconvertible inferior vena cava filter intended to provide temporary protection from pulmonary embolism. It is designed to be implanted in the IVC and later incorporate into the vessel wall, maintaining a patent lumen.
Clinical Applications
The Sentry IVC Filter is commonly used in patients requiring short-term protection from pulmonary embolism, particularly in cases where anticoagulation therapy is contraindicated or ineffective.
Evidence Summary
The available literature includes five studies, with types ranging from prospective trials to experimental models, conducted between 2019 and 2020. These studies assess the device's safety, effectiveness, and bioconversion process.
Reported Outcomes
Published studies report that the Sentry IVC Filter effectively provides temporary protection against pulmonary embolism and successfully bioconverts, integrating into the vessel wall. The two-year outcomes indicate sustained patency of the IVC lumen post-bioconversion.
Safety Profile
Reported complications include minimal adverse events related to the implantation and bioconversion process. The studies highlight a favorable safety profile with no significant device-related complications over the observed periods.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and short follow-up durations. Further research is needed to assess long-term outcomes and potential rare complications associated with the device.
Frequently Asked Questions
What are the clinical indications for Sentry IVC Filter?
The Sentry IVC Filter is indicated for patients requiring temporary protection from pulmonary embolism, especially when anticoagulation is contraindicated.
What outcomes have been reported in clinical studies?
Studies report effective temporary protection from pulmonary embolism and successful bioconversion with maintained IVC patency.
What complications have been reported?
Reported complications include minimal adverse events, with studies indicating a favorable safety profile and no significant device-related issues.
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.