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balt introducer
Target Therapeutics
Summary: The Balt Introducer is a medical device used in embolization procedures. It is primarily used for introducing catheters into the vascular system. Key evidence highlights its role in treating cerebral aneurysms.
FDA Clearance Information
Pathway
510K
Number
K925633 ↗
Decision Date
June 25, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Balt Introducer was cleared by the FDA through the 510(k) pathway on June 25, 1993. It is manufactured by Target Therapeutics and classified as a Class 2 device.
What It Is
The Balt Introducer is a medical device designed to facilitate the introduction of catheters into the vascular system. It is used in embolization procedures, particularly for the treatment of cerebral aneurysms.
Clinical Applications
The device is commonly used in interventional neuroradiology for the treatment of cerebral aneurysms. It provides access for catheters during embolization procedures, aiding in the delivery of therapeutic agents.
Evidence Summary
The literature includes three studies, with publication years ranging from 2012 to 2013. The studies encompass various designs, including case reports and retrospective analyses, focusing on the use of stents in aneurysm treatment.
Reported Outcomes
Published studies report varying degrees of aneurysm occlusion, with some achieving complete or near-complete occlusions. In one study, four cases resulted in complete occlusions, while three had near-complete occlusions, and two showed more than 50% reduction.
Safety Profile
Reported complications include a fatal hemorrhagic complication, likely related to antiplatelet treatment. Other studies did not specify additional safety concerns.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of randomized controlled trials. Further research is needed to establish long-term efficacy and safety, as well as to explore broader clinical applications.
Frequently Asked Questions
What are the clinical indications for Balt Introducer?
The Balt Introducer is indicated for use in embolization procedures, particularly for treating cerebral aneurysms.
What outcomes have been reported in clinical studies?
Studies have reported outcomes such as complete and near-complete aneurysm occlusions, with some cases achieving more than 50% reduction.
What complications have been reported?
Safety data from evidence indicate a fatal hemorrhagic complication, potentially due to antiplatelet treatment.
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.