📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Introduction of catheters into the vascular system during endovascular procedures.
- Use as an introducer or access component for catheter-based embolization procedures.
Clinical Applications
- Obtaining vascular access for delivery of interventional catheters.
- Supporting catheter-based embolization procedures.
- Providing access for endovascular treatment of vascular abnormalities when used according to the device labeling and compatible catheter system.
Reported off-label uses
- Use as an access component in embolization procedures involving vessels or clinical indications not specifically described in the original labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The introducer must be matched to the access catheter, guidewire, sheath, and vascular access site; users should follow the current product labeling for compatible sizes and components.
- The device is typically placed through percutaneous vascular access under fluoroscopic or other appropriate imaging guidance.
- Potential complications are related to vascular access and catheterization, including bleeding, hematoma, vessel injury, thrombosis, infection, embolization, and contrast-related reactions.
- MRI safety depends on the exact device model and materials. Confirm the current labeling and MR status before MRI; do not assume that an older introducer is MR safe.
- This is generally a single-use device. It should not be reused or resterilized unless the current manufacturer labeling specifically permits it.
Procedures that use this device
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.