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Agilis Hispro Steerable Catheter with Electrodes
Abbott (St. Jude Medical)
Summary: The Agilis HisPro Steerable Catheter by Abbott is designed for cardiac pacing procedures, particularly left bundle branch area pacing. Key evidence highlights its use in improving electrical resynchronization in cardiac resynchronization therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K200721 ↗
Decision Date ?
June 3, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Agilis HisPro Steerable Catheter was cleared by the FDA through the 510(k) pathway on June 3, 2020. It is manufactured by Abbott and classified as a Class 2 device.
What It Is
The Agilis HisPro Steerable Catheter is a medical device used in cardiac pacing procedures. It features electrodes and a steerable mechanism to facilitate precise placement in the heart's conduction system, specifically targeting the left bundle branch area.
FDA-Cleared Indications
- Used to facilitate the placement of cardiac pacing leads during pacing procedures.
- Designed for percutaneous navigation and positioning within the heart using fluoroscopic guidance.
- The device is indicated for use in the cardiac conduction system, including procedures involving His-bundle or left bundle branch area pacing, where consistent with the cleared labeling.
Clinical Applications
- Guiding and positioning pacing leads during cardiac implant procedures.
- Supporting left bundle branch area pacing.
- Supporting His-bundle or conduction-system pacing procedures when used within the cleared indication.
- Assisting lead positioning during cardiac resynchronization therapy procedures.
Evidence Summary
The literature includes three studies ranging from 2022 to 2024, comprising case reports and other study designs. These studies explore the feasibility and effectiveness of the device in cardiac pacing.
Reported Outcomes
Published studies report that the Agilis HisPro Steerable Catheter is effective in facilitating left bundle branch area pacing, providing better electrical resynchronization compared to traditional methods. The device supports safe and effective lead placement, enhancing cardiac resynchronization therapy outcomes.
Safety Profile
Reported complications include challenges in lead placement due to the device's design, which may require technical expertise. However, no specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy outcomes.
Practical Considerations
- The catheter is intended for percutaneous cardiac use and is typically advanced through a venous access site under fluoroscopic imaging.
- The operator must confirm compatibility with the intended pacing lead, introducer, generator system and other procedural equipment before use.
- Steerability can assist with target selection, but excessive force or manipulation may cause vascular or cardiac injury, perforation, arrhythmia or other complications.
- MRI conditions should be verified for the complete implanted pacing system and lead configuration; the catheter itself should not be assumed to be MRI safe after placement.
- The catheter is a sterile, single-use device and should not be reused or resterilized.
Frequently Asked Questions
What are the clinical indications for Agilis HisPro Steerable Catheter?
The device is indicated for use in cardiac resynchronization therapy and left bundle branch area pacing, particularly in patients requiring precise lead placement.
What outcomes have been reported in clinical studies?
Studies have reported improved electrical resynchronization and effective lead placement in cardiac pacing procedures using the device.
What complications have been reported?
Reported complications include technical challenges in lead placement, though specific adverse events were not detailed in the studies.
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.