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occlusion balloon catheter
Sentreheart
Summary: The occlusion balloon catheter by Sentreheart is used primarily in vascular interventions to temporarily occlude blood flow. Key evidence highlights its role in managing hemorrhage and supporting stent-graft placement.
FDA Clearance Information
Pathway
510K
Number
K070126 ↗
Decision Date
February 8, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The occlusion balloon catheter was cleared by the FDA via the 510(k) pathway on February 8, 2008. It is manufactured by Sentreheart and classified as a Class 2 device.
What It Is
The occlusion balloon catheter is a medical device designed to temporarily block blood flow in a vessel. It is used in various clinical settings, including vascular interventions and hemorrhage control.
Clinical Applications
Commonly used in procedures such as resuscitative endovascular balloon occlusion of the aorta (REBOA) and during stent-graft placements to manage bleeding. It provides a temporary occlusion to facilitate surgical or interventional procedures.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2020 to 2024, providing a comprehensive view of the device's clinical applications.
Reported Outcomes
Published studies report that the occlusion balloon catheter is effective in controlling hemorrhage and supporting stent-graft placement. Technical success rates are high, with significant improvements in hemodynamic stability during procedures.
Safety Profile
Reported complications include loop formation during REBOA and procedure-related adverse events. However, the overall safety profile is favorable, with low 30-day mortality rates in evaluated cases.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term outcome data. Further research is needed to explore the device's efficacy in diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for occlusion balloon catheter?
The occlusion balloon catheter is indicated for use in vascular interventions to temporarily occlude blood flow, such as in REBOA and during stent-graft placements.
What outcomes have been reported in clinical studies?
Studies report high technical success rates and improved hemodynamic stability during procedures using the occlusion balloon catheter.
What complications have been reported?
Safety data indicate complications such as loop formation during REBOA and procedure-related adverse events, though these are relatively infrequent.
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.