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cardima inc forerunner
Cardima
Summary: The Cardima Inc Forerunner is a venous stent used to support veins and improve blood flow. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K951603 ↗
Decision Date
October 5, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cardima Inc Forerunner received FDA clearance through the 510(k) pathway on October 5, 1995. It is manufactured by Cardima and classified as a Class 2 medical device.
What It Is
The Cardima Inc Forerunner is a venous stent designed to be implanted in veins to maintain patency and improve blood flow. It is typically made of a biocompatible metal mesh that expands once deployed in the vessel. This device is used to treat venous obstructions and is critical in procedures where maintaining vein openness is necessary.
Clinical Applications
This device is commonly used in procedures addressing venous insufficiency or blockages, such as in cases of deep vein thrombosis or post-thrombotic syndrome. Interventional cardiologists and vascular surgeons often use it in hospital settings, particularly in catheterization labs. It is suitable for adult patients who require venous stenting to alleviate symptoms related to venous obstruction.
Indications for Use
The FDA indications for the Cardima Inc Forerunner include use in patients with venous obstructions that require stenting to restore or maintain adequate blood flow. It is particularly beneficial for those with conditions like chronic venous insufficiency.
Practical Considerations
The Cardima Inc Forerunner comes in various sizes to accommodate different vein diameters. It is compatible with standard delivery systems used in venous stenting procedures. Clinicians should ensure proper sizing and placement to optimize outcomes and reduce the risk of migration or restenosis.
Frequently Asked Questions
What is Cardima Inc Forerunner used for?
The Cardima Inc Forerunner is used to treat venous obstructions by maintaining vein patency and improving blood flow.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with venous obstructions needing stenting to restore or maintain blood flow.
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.