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intra-aortic balloon pump catheter - modification
Kontron Instruments
Summary: The intra-aortic balloon pump catheter by Kontron Instruments is a device used for mechanical circulatory support in patients with cardiac conditions. Key evidence highlights its use in various arterial approaches and its role in hemodynamic support.
FDA Clearance Information
Pathway
510K
Number
K923603 ↗
Decision Date
March 8, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intra-aortic balloon pump catheter was cleared by the FDA through the 510(k) pathway on March 8, 1993. It is manufactured by Kontron Instruments and is classified as a Class 2 device.
What It Is
The intra-aortic balloon pump catheter is a mechanical device designed to provide temporary circulatory support by augmenting cardiac output. It is primarily used in patients with cardiac conditions such as heart failure or during cardiac surgery.
Clinical Applications
Common clinical scenarios for this device include use in patients with advanced heart failure, postcardiotomy shock, and as a bridge to cardiac transplantation. It is often inserted via femoral, axillary, or iliac artery approaches.
Evidence Summary
The available literature includes 15 studies, comprising case series and various study designs, published between 2018 and 2024. These studies explore different catheter placement techniques and clinical outcomes.
Reported Outcomes
Published studies report that the intra-aortic balloon pump catheter can effectively support hemodynamic stability in patients with cardiac conditions. Outcomes include improved cardiac output and potential for early ambulation in long-term use. The device has been used successfully in novel arterial approaches, such as the left external iliac artery.
Safety Profile
Reported complications include issues related to catheter placement, such as incorrect positioning and variability in radiopaque markers. Some studies highlight the importance of imaging in ensuring proper catheter placement to avoid adverse events.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to standardize placement techniques and to evaluate long-term outcomes and safety.
Frequently Asked Questions
What are the clinical indications for intra-aortic balloon pump catheter?
The device is indicated for mechanical circulatory support in patients with cardiac conditions such as heart failure and during cardiac surgery.
What outcomes have been reported in clinical studies?
Studies report improved hemodynamic stability, increased cardiac output, and successful use in various arterial approaches.
What complications have been reported?
Safety data indicate complications related to catheter placement, including incorrect positioning and variability in radiopaque markers.
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.