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guidant microwave ablation system
Guidant Corporation, Cardiac Surgery
Summary: The Guidant Microwave Ablation System is a device used for minimally invasive surgical ablation of atrial fibrillation. Key evidence highlights its use in thoracoscopic procedures with some reported success in atrial fibrillation management.
FDA Clearance Information
Pathway
510K
Number
K041340 ↗
Decision Date
July 28, 2004
Product Code
NEY
Device Class
Class 2
Evidence
0 studies
The Guidant Microwave Ablation System received FDA clearance through the 510(k) pathway on July 28, 2004. It is manufactured by Guidant Corporation, Cardiac Surgery, and is classified as a Class 2 device under product code NEY.
What It Is
The Guidant Microwave Ablation System is designed for the ablation of cardiac tissue using microwave energy. It is primarily used in the surgical treatment of atrial fibrillation, particularly in minimally invasive thoracoscopic procedures.
Clinical Applications
This device is commonly used in the surgical management of atrial fibrillation, especially in patients undergoing minimally invasive thoracoscopic procedures. It is suitable for patients with both stand-alone and concomitant atrial fibrillation.
Evidence Summary
The available literature includes four studies, comprising case reports and clinical trials, conducted between 2006 and 2009. These studies explore the device's application in atrial fibrillation treatment using minimally invasive techniques.
Reported Outcomes
Published studies report that the Guidant Microwave Ablation System is effective in achieving successful ablation in atrial fibrillation cases. The thoracoscopic approach has shown promise in reducing atrial fibrillation episodes, with some studies indicating improved patient outcomes post-procedure.
Safety Profile
Reported complications include potential risks associated with thoracoscopic procedures, such as bleeding and infection. However, specific safety data from the provided studies is limited, necessitating further investigation.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to establish long-term efficacy and safety, as well as to explore outcomes in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Guidant Microwave Ablation System?
The device is indicated for the surgical ablation of atrial fibrillation, particularly in minimally invasive thoracoscopic procedures.
What outcomes have been reported in clinical studies?
Studies have reported successful ablation and reduction in atrial fibrillation episodes, with some improvement in patient outcomes.
What complications have been reported?
Reported complications include risks associated with thoracoscopic procedures, such as bleeding and infection, though specific data is limited.
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.