đź“Š Evidence-Based Reference
usci probing catheter
C.R. Bard
Summary: The USCI Probing Catheter by C.R. Bard is a Class 2 device used in venous stents. Key evidence includes its application in coronary angioplasty and associated safety concerns.
FDA Clearance Information
Pathway
510K
Number
K890152 ↗
Decision Date
August 17, 1989
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The USCI Probing Catheter was cleared by the FDA via the 510(k) pathway on August 17, 1989. It is manufactured by C.R. Bard and classified as a Class 2 device.
What It Is
The USCI Probing Catheter is a medical device designed for use in venous stenting procedures. It facilitates the probing and dilation of vessels, aiding in the treatment of vascular conditions.
Clinical Applications
Commonly used in scenarios requiring coronary angioplasty, the USCI Probing Catheter is instrumental in traversing tight stenoses and facilitating vessel dilation in multivessel coronary interventions.
Evidence Summary
The literature includes 10 studies ranging from 1991 to 1996, covering various clinical applications of the catheter. Study types include case series and other observational designs.
Reported Outcomes
Published studies report the catheter's efficacy in facilitating coronary angioplasty, particularly in traversing tight stenoses. It has been used successfully in multivessel procedures and total occlusions.
Safety Profile
Reported complications include balloon rupture leading to coronary artery dissection and occlusion. These events highlight the need for careful handling and monitoring during procedures.
Evidence Limitations
The evidence is limited by the small number of studies and lack of recent data. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for USCI Probing Catheter?
The USCI Probing Catheter is indicated for use in venous stenting and coronary angioplasty procedures, particularly in cases involving tight stenoses.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful outcomes in coronary angioplasty, with the catheter effectively traversing tight stenoses and facilitating vessel dilation.
What complications have been reported?
Safety data from evidence indicate complications such as balloon rupture, which can lead to coronary artery dissection and occlusion.
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.