đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The available FDA record identifies this product as a Class II intra-aortic balloon pump catheter cleared through the 510(k) pathway under product code DYB.
- Use is intended for temporary mechanical circulatory support with an intra-aortic balloon pump in patients requiring hemodynamic assistance.
Clinical Applications
- Temporary circulatory support for selected patients with severe cardiac dysfunction or hemodynamic instability.
- Hemodynamic support during or after cardiac surgery when the heart cannot maintain adequate circulation.
- Support during selected episodes of cardiogenic shock or acute cardiac decompensation, when consistent with the device labeling and clinical judgment.
- Temporary support while evaluating or preparing for definitive treatment, such as revascularization, durable mechanical support, or transplantation.
Reported off-label uses
- Bridge support for selected patients awaiting durable ventricular assist-device placement or heart transplantation.
- Temporary support during high-risk cardiac procedures or interventions in patients with limited cardiac reserve.
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 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.
Practical Considerations
- The catheter is typically inserted through the common femoral artery and advanced into the descending thoracic aorta; alternative access, including axillary or iliac access, may be considered in selected patients.
- Correct balloon and catheter size must be matched to the patient's aortic dimensions, height, vascular anatomy, and the specific pump console.
- Placement and position are confirmed with fluoroscopy, chest radiography, or another appropriate imaging method. The balloon should not obstruct the branch vessels of the aortic arch or extend into the renal arteries.
- Important risks include limb ischemia, bleeding, vascular injury, aortic injury, thrombocytopenia, infection, balloon rupture, and embolization. Severe peripheral arterial disease, aortic dissection, significant aortic regurgitation, and uncontrolled bleeding may be contraindications or require special assessment.
- IABP catheters and consoles are not generally considered MRI-safe as a complete system. MRI compatibility must be verified for the exact catheter, console, and clinical setup before scanning.
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.