đź“Š Evidence-Based Reference
venture wire control catheter
Velocimed
Summary: The Venture Wire Control Catheter is a steerable catheter used primarily in complex coronary interventions. Key evidence highlights its utility in challenging anatomical scenarios.
FDA Clearance Information
Pathway
510K
Number
K040922 ↗
Decision Date
August 18, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Venture Wire Control Catheter was cleared by the FDA via the 510(k) pathway on August 18, 2004. It is manufactured by Velocimed and classified as a Class 2 device.
What It Is
The Venture Wire Control Catheter is a steerable catheter designed for precise navigation in complex vascular anatomy. It is intended for use in percutaneous interventions, particularly in challenging coronary and venous procedures.
Clinical Applications
Commonly used in scenarios such as chronic total occlusions, bifurcation lesions, and complex coronary interventions, the Venture catheter aids in navigating difficult-to-wire lesions and accessing side branches.
Evidence Summary
The literature includes 10 studies ranging from 2011 to 2024, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies explore the catheter's efficacy in complex interventions.
Reported Outcomes
Published studies report that the Venture catheter facilitates successful navigation and intervention in complex coronary and venous anatomies. It has been shown to reduce door-to-balloon time in acute myocardial infarction and improve success rates in accessing challenging lesions.
Safety Profile
Reported complications include potential risks associated with catheter manipulation in complex anatomies, although specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small sample sizes and lack of detailed safety data. Further research is needed to establish long-term outcomes and comprehensive safety profiles.
Frequently Asked Questions
What are the clinical indications for Venture Wire Control Catheter?
The catheter is indicated for use in complex coronary interventions, including chronic total occlusions and bifurcation lesions.
What outcomes have been reported in clinical studies?
Studies report improved success rates in navigating complex lesions and reduced door-to-balloon times in myocardial infarction cases.
What complications have been reported?
Safety data is limited, but potential complications may arise from catheter manipulation in complex anatomies.
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.