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supercross catheter
Abbott Vascular
Summary: The Supercross catheter by Abbott Vascular is a steerable microcatheter used primarily in complex coronary interventions. Key evidence highlights its utility in challenging anatomical scenarios.
FDA Clearance Information
Pathway
510K
Number
K001856 ↗
Decision Date
March 7, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Supercross catheter was cleared via the FDA 510(k) pathway on March 7, 2001. It is manufactured by Abbott Vascular and classified as a Class 2 device under product code DQY.
What It Is
The Supercross catheter is a steerable microcatheter designed for use in complex percutaneous coronary interventions. It facilitates navigation through challenging vascular anatomy, aiding in precise delivery of therapeutic agents or devices.
Clinical Applications
Commonly used in scenarios involving complex coronary artery lesions, the Supercross catheter is particularly beneficial in navigating tortuous or stenotic vessels, often encountered in patients with prior surgical interventions.
Evidence Summary
The literature includes three studies from 2021 to 2024, encompassing various study designs such as RCTs and case series. These studies explore the catheter's application in complex coronary and pulmonary artery interventions.
Reported Outcomes
Published studies report the Supercross catheter's effectiveness in navigating complex vascular anatomy, particularly in coronary and pulmonary interventions. Its steerability and precision are highlighted as key benefits in achieving successful outcomes.
Safety Profile
Reported complications include challenges related to catheter navigation in extremely tortuous vessels. However, specific adverse events are not detailed in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety data. Further research is needed to establish comprehensive safety profiles and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Supercross catheter?
The Supercross catheter is indicated for use in complex percutaneous coronary interventions, particularly in navigating challenging vascular anatomy.
What outcomes have been reported in clinical studies?
Studies report successful navigation and intervention in complex coronary and pulmonary artery cases, highlighting the catheter's precision and steerability.
What complications have been reported?
Reported complications include navigation challenges in tortuous vessels, but specific adverse events are 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.