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biopore vs 1 endocardial inter implant pacing lead
Intermedics
Summary: The Biopore VS 1 is an endocardial pacing lead used in cardiac pacing systems. It is primarily utilized by cardiologists for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K883602 ↗
Decision Date
September 6, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biopore VS 1 was cleared through the FDA 510(k) pathway on September 6, 1988. Manufactured by Intermedics, it is classified as a Class III medical device.
What It Is
The Biopore VS 1 Endocardial Inter Implant Pacing Lead is a component of cardiac pacing systems, designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. It is implanted inside the heart via the venous system and connects to a pacemaker device. The lead features a biopore design to enhance tissue in-growth and stability within the heart chamber.
Clinical Applications
This device is commonly used in cardiology, particularly in the implantation of pacemakers for patients with arrhythmias or heart block. It is typically used in hospital settings, including cardiac catheterization labs and electrophysiology suites. The patient population includes those with bradycardia or other conditions requiring electrical pacing support.
Indications for Use
The Biopore VS 1 is indicated for patients who require cardiac pacing due to conditions like heart block or severe bradycardia. It is suitable for individuals who need a reliable method to maintain heart rhythm.
Practical Considerations
The Biopore VS 1 is available in various lengths to accommodate different patient anatomies. It is compatible with standard pacemaker generators. Proper technique during implantation is crucial to ensure lead stability and minimize complications.
Frequently Asked Questions
What is Biopore VS 1 Endocardial Inter Implant Pacing Lead used for?
It is used for delivering electrical impulses to the heart to maintain a regular heart rate in patients requiring pacemaker support.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to conditions like heart block or severe bradycardia.
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.