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tendril unipolar endocardial screw-in lead
Pacesetter
Summary: The Tendril Unipolar Endocardial Screw-In Lead is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists in settings where cardiac pacing is required.
FDA Clearance Information
Pathway
510K
Number
K951087 ↗
Decision Date
June 29, 1995
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Tendril Unipolar Endocardial Screw-In Lead was cleared via the FDA 510k pathway on June 29, 1995. Manufactured by Pacesetter, it is classified as a Class III medical device.
What It Is
The Tendril Unipolar Endocardial Screw-In Lead is a type of cardiac lead used in pacemaker systems. It features a screw-in mechanism that allows for secure attachment to the heart muscle, ensuring reliable delivery of electrical impulses. This lead is unipolar, meaning it has a single electrode that contacts the heart tissue, which is crucial for effective cardiac pacing.
Clinical Applications
This device is commonly used in the implantation of pacemakers, particularly in patients with bradycardia or other conditions requiring cardiac pacing. It is typically utilized by cardiologists and electrophysiologists in hospital settings, including operating rooms and cardiac catheterization labs. The patient population includes those with heart rhythm disorders who require long-term pacing support.
Indications for Use
The FDA indications suggest that this lead is intended for use in patients who need cardiac pacing due to conditions like bradycardia. It is suitable for individuals who require a reliable means of delivering electrical impulses to stimulate heart contractions.
Practical Considerations
The Tendril Unipolar Lead is designed to be compatible with various pacemaker models. It is important to consider the lead length and screw-in mechanism during implantation to ensure proper placement and function. Clinicians should be familiar with the handling and insertion techniques specific to unipolar leads.
Frequently Asked Questions
What is the Tendril Unipolar Endocardial Screw-In Lead used for?
It is used for delivering electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The lead is indicated for patients needing cardiac pacing due to conditions like 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.