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atherocath-bantam tm directional coronary atherectomy system
Abbott Vascular
Summary: The Atherocath-Bantam TM is a directional coronary atherectomy system used for treating coronary artery disease. Key evidence highlights its role in managing calcified lesions.
FDA Clearance Information
Pathway
PMA
Number
P890043 ↗
Decision Date
June 8, 1998
Product Code
MCX
Device Class
Class 3
Evidence
0 studies
The Atherocath-Bantam TM was cleared by the FDA via the PMA pathway on June 8, 1998. It is manufactured by Abbott Vascular and classified as a Class 3 device.
What It Is
The Atherocath-Bantam TM is a directional coronary atherectomy system designed to remove atherosclerotic plaque from coronary arteries. It is used in interventional cardiology to treat coronary artery disease, particularly in cases involving calcified lesions.
Clinical Applications
This device is commonly used in percutaneous coronary interventions (PCI) for patients with severe coronary artery calcification. It is particularly beneficial in scenarios where traditional balloon angioplasty and stenting are insufficient due to calcified obstructions.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses, published between 2019 and 2025. These studies focus on the device's efficacy and safety in treating calcified coronary lesions.
Reported Outcomes
Published studies report that the Atherocath-Bantam TM is effective in facilitating stent expansion in severely calcified coronary lesions. The device has shown promise in improving procedural success rates in complex PCI cases. However, specific quantitative outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include procedural challenges associated with heavily calcified lesions, which may lead to periprocedural complications. The evidence does not provide detailed safety data specific to the Atherocath-Bantam TM.
Evidence Limitations
The evidence lacks detailed quantitative outcomes and comprehensive safety data specific to the Atherocath-Bantam TM. Further research is needed to establish long-term efficacy and safety profiles in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Atherocath-Bantam TM?
The device is indicated for use in coronary artery disease, particularly in cases involving severe calcification where traditional methods are inadequate.
What outcomes have been reported in clinical studies?
Studies suggest the device is effective in improving procedural success in calcified lesions, though specific quantitative outcomes are not detailed.
What complications have been reported?
Reported complications include procedural challenges with calcified lesions, but specific safety data for the device is limited in the evidence provided.
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.