📊 Evidence-Based Reference
Impella Cp Introducer
Summary: The Impella CP Introducer by Abiomed is a device used for cardiac support, primarily in patients with cardiogenic shock. Key evidence suggests that using a large-bore sheath may reduce access site bleeding.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K192769 ↗
Decision Date ?
November 18, 2019
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Impella CP Introducer was cleared by the FDA via the 510(k) pathway on November 18, 2019. It is manufactured by Abiomed and classified as a Class 2 device under product code DYB.
What It Is
The Impella CP Introducer is a percutaneous device designed to provide temporary mechanical circulatory support. It is used in clinical settings to assist patients with severe cardiac conditions, such as cardiogenic shock, by facilitating the insertion of the Impella heart pump.
FDA-Cleared Indications
- Facilitates percutaneous insertion of the Impella CP device through the arterial system.
- Provides access for temporary mechanical circulatory support with the Impella CP pump during indicated cardiac procedures.
Clinical Applications
- Femoral arterial access for placement of an Impella CP pump in patients requiring temporary mechanical circulatory support.
- Use during catheter-based treatment of cardiogenic shock when Impella CP support is indicated.
- Use during selected high-risk percutaneous coronary intervention procedures when temporary circulatory support is indicated.
Evidence Summary
The literature includes two peer-reviewed studies, with publication years ranging from 2021 to 2025. These studies encompass various methodologies, including randomized controlled trials and case series, focusing on the efficacy and safety of the device.
Reported Outcomes
Published studies report that using a 16 Fr sheath during Impella support significantly reduces access site major bleeding compared to conventional sheaths, with a bleeding rate of 33.0% versus 64.0%, respectively. The adjusted odds ratio for bleeding was 0.294, indicating a statistically significant reduction.
Safety Profile
Reported complications include access site bleeding and potential limb ischemia. However, the use of antegrade perfusion with a 4Fr sheath was noted to prevent limb ischemia effectively at the Impella site.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for further research to confirm the long-term safety and efficacy of the large-bore sheath strategy. Additional studies are required to explore other potential complications and optimize device use.
Practical Considerations
- This is a large-bore arterial introducer and requires assessment of vessel size, calcification, tortuosity and peripheral arterial disease before placement.
- The access site is typically the common femoral artery, with imaging guidance and vascular-access management used to reduce complications.
- Compatibility is limited to the intended Impella CP system and associated accessories; the manufacturer's instructions for use should be followed.
- Potential complications include bleeding, hematoma, limb ischemia, arterial injury, thrombosis, infection and need for vascular repair.
- MRI safety and conditions depend on the specific introducer and the complete Impella system; it should not be considered MRI safe unless the current device labeling confirms the applicable conditions.
Frequently Asked Questions
What are the clinical indications for Impella CP Introducer?
The Impella CP Introducer is indicated for use in patients requiring mechanical circulatory support, such as those with cardiogenic shock or undergoing high-risk cardiac procedures.
What outcomes have been reported in clinical studies?
Clinical studies have reported a significant reduction in access site bleeding when using a 16 Fr sheath compared to conventional sheaths.
What complications have been reported?
Safety data from evidence indicate complications such as access site bleeding and potential limb ischemia, although the latter can be mitigated with antegrade perfusion.
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.