📊 Evidence-Based Reference
Introducing Catheter
Devices For Vascular Intervention
Summary: The introducing catheter by Devices For Vascular Intervention is a Class 2 medical device used primarily in embolization procedures. Key evidence highlights its role in renal denervation for hypertension management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K883933 ↗
Decision Date ?
December 2, 1988
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The introducing catheter was cleared by the FDA via the 510(k) pathway on December 2, 1988. It is manufactured by Devices For Vascular Intervention and classified as a Class 2 device.
What It Is
The introducing catheter is a medical device designed for use in vascular interventions, particularly for embolization procedures. It facilitates the introduction of other instruments or agents into the vascular system.
FDA-Cleared Indications
- Used to introduce and guide other vascular instruments or agents during endovascular procedures.
- Intended for vascular access and delivery in procedures requiring catheter-based navigation within the blood vessels.
Clinical Applications
- Providing vascular access for embolization procedures
- Delivering catheters or embolic materials to selected arteries
- Supporting catheter-based treatment of aneurysms, arteriovenous malformations, or bleeding vessels when consistent with the device labeling
- Facilitating selective access to renal or other visceral arteries during endovascular intervention
Reported off-label uses
- Use as part of renal denervation procedures for resistant hypertension
- Use in intra-aneurysmal embolization when the specific catheter configuration is not separately labeled for that application
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 15 studies, encompassing RCTs, prospective, and retrospective analyses, published between 2012 and 2017. These studies explore various clinical applications and outcomes of the introducing catheter.
Reported Outcomes
Published studies report that the introducing catheter is effective in facilitating renal denervation, reducing hypertension in resistant cases. It also shows efficacy in embolization procedures, with angiographic results indicating complete occlusion in some cases.
Safety Profile
Reported complications include symptomatic embolism, persistent symptomatic complications, and heparinization-related risks. Some studies noted potential risks of hemorrhage associated with heparinization during procedures.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some cases. Further research is needed to establish long-term outcomes and safety profiles across diverse patient populations.
Practical Considerations
- The appropriate catheter size, length, tip configuration, and guidewire compatibility must be confirmed from the current manufacturer labeling.
- Use requires fluoroscopic or other appropriate imaging guidance and careful assessment of vessel size, tortuosity, and access-site anatomy.
- Compatibility with guidewires, diagnostic catheters, microcatheters, contrast agents, and embolic materials should be checked before use.
- MRI safety should not be assumed from the 510(k) record; review the current labeling for MR Safe, MR Conditional, or MR Unsafe status.
- Potential complications include vascular injury, bleeding, dissection, thrombosis, embolization, infection, contrast reaction, and loss of catheter integrity.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for introducing catheter?
The introducing catheter is indicated for use in embolization procedures and renal denervation for hypertension management.
What outcomes have been reported in clinical studies?
Studies report effective reduction in hypertension and successful embolization outcomes, including complete occlusion in some cases.
What complications have been reported?
Safety data indicate risks of symptomatic embolism, heparinization-related complications, and potential hemorrhage.
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.