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coda lp balloon catheter
Cook
Summary: The Coda LP Balloon Catheter is a device used for vascular occlusion in trauma settings. It is primarily used in resuscitative endovascular balloon occlusion of the aorta (REBOA). Key evidence includes studies on its use in swine models and cost-effective simulation training.
FDA Clearance Information
Pathway
510K
Number
K150970 ↗
Decision Date
May 12, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Coda LP Balloon Catheter was cleared by the FDA through the 510(k) pathway on May 12, 2015. It is manufactured by Cook and classified as a Class 2 device under product code DQY.
What It Is
The Coda LP Balloon Catheter is a medical device designed for temporary vascular occlusion. It is used in clinical settings to control hemorrhage by occluding large blood vessels, particularly in trauma cases involving noncompressible torso hemorrhage.
Clinical Applications
Commonly used in trauma settings, the Coda LP Balloon Catheter is employed in procedures such as resuscitative endovascular balloon occlusion of the aorta (REBOA). It is particularly useful in managing severe hemorrhage when traditional methods are insufficient.
Evidence Summary
The available literature includes two studies, one from 2017 and another from 2024. These studies encompass a range of methodologies, including validation studies in swine and the development of simulation models for training.
Reported Outcomes
Published studies report the effectiveness of the Coda LP Balloon Catheter in simulating REBOA procedures and its potential for training purposes. The device has been shown to be a valuable tool in both animal models and simulation environments, aiding in the development of skills necessary for effective hemorrhage control.
Safety Profile
Reported complications include the challenges associated with the use of large animals and the resource-intensive nature of current training paradigms. No specific adverse events related to the device itself were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on simulation and animal models rather than human clinical trials. Further research is needed to validate these findings in diverse clinical settings and to explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Coda LP Balloon Catheter?
The Coda LP Balloon Catheter is indicated for use in vascular occlusion procedures, particularly in trauma settings for controlling hemorrhage.
What outcomes have been reported in clinical studies?
Studies have reported the device's effectiveness in simulating REBOA procedures and its utility in training environments.
What complications have been reported?
Reported complications include the logistical challenges of current training methods, with no specific adverse events noted in the studies provided.
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.