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tir tij and polyrox
Biotronik
Summary: Tir tij and polyrox is a medical device manufactured by Biotronik, primarily used in the context of IVC filters. Key evidence includes studies on pacemaker longevity and orthopedic health traits.
FDA Clearance Information
Pathway
510K
Number
K972500 ↗
Decision Date
March 4, 1998
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The tir tij and polyrox device was cleared by the FDA through the 510(k) pathway on March 4, 1998. It is manufactured by Biotronik and classified as a Class III device.
What It Is
Tir tij and polyrox is a device used in the clinical category of IVC filters. It is designed to prevent pulmonary embolism by capturing blood clots that travel from the lower extremities to the lungs.
Clinical Applications
This device is commonly used in patients at risk of pulmonary embolism, particularly those who cannot tolerate anticoagulation therapy. It is often deployed in surgical or trauma patients with a high risk of venous thromboembolism.
Evidence Summary
The available literature includes two studies, one focusing on pacemaker longevity and the other on orthopedic health traits in horses. These studies were published in 2005 and 2015, respectively, and include various study types.
Reported Outcomes
Published studies report on the longevity of pacemakers and the compatibility of orthopedic health traits with performance in horses. However, specific outcomes related to tir tij and polyrox are not detailed in the provided evidence.
Safety Profile
Reported complications include general concerns related to pacemaker longevity and orthopedic health, but specific safety data for tir tij and polyrox is not available in the provided studies.
Evidence Limitations
The evidence provided does not directly address the efficacy or safety of tir tij and polyrox. Further research is needed to evaluate its specific clinical outcomes and potential complications.
Frequently Asked Questions
What are the clinical indications for tir tij and polyrox?
Clinical indications are detailed in the FDA documentation, primarily related to the prevention of pulmonary embolism in patients at risk.
What outcomes have been reported in clinical studies?
The studies provided focus on pacemaker longevity and orthopedic health traits, with no specific outcomes for tir tij and polyrox.
What complications have been reported?
Safety data specific to tir tij and polyrox is not available in the provided evidence. General concerns relate to device longevity and compatibility with health traits.
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.