📊 Evidence-Based Reference
Coda LP Balloon Catheter
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 ?
510(k)
Number ?
K150970 ↗
Decision Date ?
May 12, 2015
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Temporary occlusion of large vessels during endovascular procedures.
- Occlusion of vessels to control or reduce blood flow during treatment.
- Use in percutaneous vascular procedures when temporary balloon obstruction is required.
Clinical Applications
- Temporary occlusion of the aorta or other large vessels during endovascular procedures.
- Balloon occlusion to assist with control of blood flow during treatment of vascular injury or hemorrhage.
- Temporary vessel occlusion during selected interventional radiology, vascular surgery, or endovascular procedures.
Reported off-label uses
- Resuscitative endovascular balloon occlusion of the aorta (REBOA) for noncompressible torso hemorrhage, where use may depend on the specific device labeling, institutional protocols, and regulatory jurisdiction.
- Temporary balloon occlusion during complex endovascular repair when the catheter's labeled indications do not specifically describe the clinical situation.
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 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.
Practical Considerations
- The catheter is selected according to the target vessel, required occlusion diameter, access sheath, and the manufacturer's available size and inflation-volume specifications.
- It is introduced percutaneously over a guidewire and positioned under fluoroscopic or other appropriate imaging guidance.
- The balloon should be inflated gradually with the recommended contrast-saline mixture and monitored closely to reduce the risk of vessel injury, rupture, migration, or ischemia.
- MRI safety depends on the exact catheter configuration and labeling; confirm the current manufacturer MRI conditions before scanning.
- Contraindications and precautions include unsuitable vessel size or anatomy, severe access-vessel disease, inability to tolerate temporary ischemia, balloon overinflation, and prolonged occlusion.
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.