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selectra cs lead introducer system
Biotronik
Summary: The Selectra CS Lead Introducer System by Biotronik is used to facilitate the placement of cardiac leads in the coronary sinus. It is primarily used by cardiologists in electrophysiology procedures.
FDA Clearance Information
Pathway
510K
Number
K110461 ↗
Decision Date
April 20, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra CS Lead Introducer System was cleared through the FDA 510(k) pathway on April 20, 2011. Manufactured by Biotronik, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Selectra CS Lead Introducer System is a medical device designed to assist in the placement of cardiac leads into the coronary sinus, a vein of the heart. It consists of a sheath and dilator that provide a pathway for the lead to be advanced into the desired position. This system is crucial in procedures where precise lead placement is necessary for optimal cardiac resynchronization therapy.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures to implant cardiac resynchronization therapy devices. Cardiologists and electrophysiologists use it to ensure accurate placement of leads in patients requiring pacing for heart failure or arrhythmias. It is particularly useful in patients with complex venous anatomies or those undergoing repeat procedures.
Indications for Use
The Selectra CS Lead Introducer System is indicated for use in patients who require the placement of cardiac leads in the coronary sinus, typically for cardiac resynchronization therapy. It is suitable for patients with heart failure or arrhythmias needing precise lead placement.
Practical Considerations
The system is available in various sizes to accommodate different patient anatomies and lead types. Compatibility with a range of lead designs is a key feature, and clinicians should be familiar with the specific techniques for using the introducer system to ensure successful lead placement.
Frequently Asked Questions
What is the Selectra CS Lead Introducer System used for?
It is used to facilitate the placement of cardiac leads in the coronary sinus during cardiac resynchronization therapy procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for the placement of cardiac leads in the coronary sinus, primarily for patients requiring cardiac resynchronization therapy.
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.