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cardima vueport coronary sinus balloon occlusion guiding catheter
Cardima
Summary: The Cardima Vueport is a coronary sinus balloon occlusion guiding catheter used primarily in cardiology for procedures involving the coronary sinus. It is utilized by interventional cardiologists to facilitate access and delivery of therapies.
FDA Clearance Information
Pathway
510K
Number
K973298 ↗
Decision Date
June 26, 1998
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cardima Vueport was cleared through the FDA 510(k) pathway on June 26, 1998. Manufactured by Cardima, it is a Class 2 device under product code DQY.
What It Is
The Cardima Vueport is a specialized catheter designed to occlude the coronary sinus temporarily. It features a balloon mechanism that allows for the occlusion of the coronary sinus, facilitating procedures such as venous mapping or delivery of therapeutic agents. This device is particularly useful in electrophysiology and interventional cardiology settings.
Clinical Applications
The device is commonly used in electrophysiology labs during procedures that require access to the coronary sinus, such as atrial fibrillation ablation or cardiac resynchronization therapy. It is also employed in settings where temporary occlusion of the coronary sinus is needed to enhance the efficacy of certain pharmacological interventions. Patients with arrhythmias or heart failure may benefit from procedures utilizing this device.
Indications for Use
The Cardima Vueport is indicated for use in procedures requiring temporary occlusion of the coronary sinus. It is suitable for patients undergoing interventions that involve the coronary venous system, particularly in the context of electrophysiological studies or therapeutic delivery.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard electrophysiology lab equipment and techniques. Clinicians should be familiar with balloon inflation techniques and the specific procedural protocols associated with coronary sinus interventions.
Related Literature
The linked study explored the use of the Cardima Vueport for pharmacological atrial defibrillation in humans via a temporarily occluded coronary sinus. The study reported initial clinical experiences and suggested potential for an implantable device. However, the study was limited by its early-stage nature and small sample size, highlighting the need for further research to confirm these findings.
Frequently Asked Questions
What is the Cardima Vueport used for?
It is used for temporarily occluding the coronary sinus during cardiac procedures, particularly in electrophysiology and interventional cardiology.
What specialties typically use this device?
Interventional cardiologists and electrophysiologists commonly use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring temporary occlusion of the coronary sinus, particularly in electrophysiological studies and therapeutic interventions.
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.