Summary: The Actifix R Bipolar Endocardial Screw-in Lead is a cardiac pacing lead used primarily for patients requiring permanent pacemaker implantation. Key evidence highlights its use in pediatric and congenital heart disease cases.
The Actifix R Bipolar Endocardial Screw-in Lead was cleared by the FDA via the 510k pathway on January 29, 1988. Manufactured by Daig, it is classified as a Class 3 medical device.
What It Is
The Actifix R is a bipolar endocardial screw-in lead designed for cardiac pacing. It is used in conjunction with a pacemaker to deliver electrical impulses to the heart, ensuring proper heart rhythm in patients with arrhythmias.
Clinical Applications
Commonly used in scenarios where transvenous pacing is required, the Actifix R is suitable for both pediatric patients and adults with congenital heart disease. It is often employed when traditional venous access is challenging.
Evidence Summary
The available literature includes three studies ranging from 2001 to 2016, covering case series and alternative pacing techniques. These studies provide insights into the device's application in pediatric and complex cardiac cases.
Reported Outcomes
Published studies report successful emergency pacing and permanent pacemaker implantation in a premature infant, with a follow-up of 6 years. Another study highlights the device's role in alternative pacing techniques for cardiac resynchronization therapy.
Safety Profile
Reported complications include challenges with myocardial screw-in leads in the past, which have led to a preference for transvenous approaches when feasible. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on specific patient populations. Further research is needed to evaluate long-term outcomes and safety in broader clinical settings.
Frequently Asked Questions
What are the clinical indications for Actifix R Bipolar Endocardial Screw-in Lead?
The device is indicated for patients requiring permanent cardiac pacing, particularly in cases where traditional venous access is limited, such as in pediatric patients and those with congenital heart disease.
What outcomes have been reported in clinical studies?
Studies have reported successful emergency pacing and permanent pacemaker implantation in a premature infant, with a 6-year follow-up showing effective pacing.
What complications have been reported?
Reported complications include historical challenges with myocardial screw-in leads, leading to a preference for transvenous approaches when possible. Specific adverse events were not detailed in the studies.
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.
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