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model 437-01 biopore implantable pacing lead
Intermedics
Summary: The Model 437-01 Biopore Implantable Pacing Lead is a cardiac device used for pacing the heart in patients with arrhythmias. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K862258 ↗
Decision Date
July 10, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 437-01 Biopore Implantable Pacing Lead was cleared by the FDA via the 510k pathway on July 10, 1986. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Model 437-01 Biopore Implantable Pacing Lead is a specialized cardiac lead designed to deliver electrical impulses to the heart, aiding in the management of arrhythmias. It is implanted into the heart muscle and connected to a pacemaker, which controls the heart's rhythm. The biopore design enhances tissue integration, reducing the risk of lead dislodgement.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. It is primarily utilized by cardiologists and electrophysiologists in hospital settings. The device is suitable for adult patients who require long-term pacing therapy.
Indications for Use
The FDA indications suggest this device is for patients with conditions that require cardiac pacing, such as slow heart rhythms or heart block. It is intended for those who need a reliable method to maintain adequate heart rate and rhythm.
Practical Considerations
The Model 437-01 lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker systems. Proper implantation technique is crucial to ensure optimal performance and minimize complications.
Frequently Asked Questions
What is the Model 437-01 Biopore Implantable Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias, particularly those with bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to slow heart rhythms or heart block.
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.