đź“Š Evidence-Based Reference
recross
Imds Operations
Summary: ReCross is a dual-lumen microcatheter designed for use in percutaneous coronary interventions, particularly in chronic total occlusions. Key evidence highlights its role in increasing procedural success rates.
FDA Clearance Information
Pathway
510K
Number
K210431 ↗
Decision Date
July 15, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
ReCross was cleared via the FDA 510(k) pathway on July 15, 2021. Manufactured by Imds Operations, it is classified as a Class 2 device under product code DQY.
What It Is
ReCross is a dual-lumen microcatheter with two over-the-wire lumens and three exit ports, facilitating antegrade dissection and re-entry in coronary interventions. It is intended for use in chronic total occlusion procedures to improve re-entry into the true lumen.
Clinical Applications
ReCross is commonly used in percutaneous coronary interventions for chronic total occlusions. It is particularly useful in scenarios requiring antegrade dissection and re-entry techniques.
Evidence Summary
The literature includes 12 studies, comprising various study types such as RCTs and observational studies, published between 2024 and 2025. These studies explore the efficacy and safety of ReCross in clinical settings.
Reported Outcomes
Published studies report that ReCross enhances procedural success rates in antegrade CTO PCI by facilitating re-entry into the true lumen. It is noted for its potential to improve outcomes in complex coronary interventions.
Safety Profile
Reported complications include the potential for extraplaque hematoma formation during antegrade dissection and re-entry procedures. However, specific adverse event rates are not detailed in the available studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and long-term outcome data. Further research is needed to fully understand the safety profile and comparative efficacy of ReCross.
Frequently Asked Questions
What are the clinical indications for ReCross?
ReCross is indicated for use in percutaneous coronary interventions, particularly in chronic total occlusions requiring antegrade dissection and re-entry techniques.
What outcomes have been reported in clinical studies?
Studies report increased procedural success rates in CTO PCI when using ReCross, particularly in facilitating re-entry into the true lumen.
What complications have been reported?
Reported complications include the formation of extraplaque hematomas during procedures, though specific rates 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.