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occlusion balloon
Boston Scientific
Summary: The occlusion balloon by Boston Scientific is a device used primarily for temporary vascular occlusion to control bleeding. Key evidence highlights its use in managing placenta accreta spectrum disorders and trauma-related hemorrhage.
FDA Clearance Information
Pathway
510K
Number
K062202 ↗
Decision Date
October 20, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The occlusion balloon by Boston Scientific was cleared via the FDA 510k pathway on October 20, 2006. It is classified as a Class 2 medical device under product code DQY.
What It Is
The occlusion balloon is a medical device designed to temporarily occlude blood vessels, aiding in the control of hemorrhage during surgical procedures. It is commonly used in interventional radiology and trauma surgery.
Clinical Applications
This device is frequently used in scenarios such as managing placenta accreta spectrum disorders and controlling traumatic hemorrhage. It provides a minimally invasive option for temporary vascular occlusion.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, retrospective, and case series, published between 2023 and 2025. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the occlusion balloon is effective in reducing blood loss during cesarean hysterectomy for placenta accreta spectrum disorders. It is also utilized in trauma settings for rapid vascular control, demonstrating its versatility in different clinical scenarios.
Safety Profile
Reported complications include potential vascular injury and ischemia due to prolonged occlusion. However, these events are generally rare and manageable with appropriate clinical oversight.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for more randomized controlled trials to establish long-term outcomes. Further research is needed to explore its efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for occlusion balloon?
The occlusion balloon is indicated for temporary vascular occlusion in procedures such as managing placenta accreta spectrum disorders and trauma-related hemorrhage.
What outcomes have been reported in clinical studies?
Studies report reduced blood loss in cesarean hysterectomy for placenta accreta spectrum disorders and effective hemorrhage control in trauma settings.
What complications have been reported?
Safety data indicate potential complications such as vascular injury and ischemia, though these are rare and typically manageable.
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.