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vivawave microwave ablation system coaxial introducer
Vivant Medical
Summary: The Vivawave Microwave Ablation System is a medical device used for the ablation of tumors. It is primarily utilized by interventional radiologists and oncologists in the treatment of cancer patients.
FDA Clearance Information
Pathway
510K
Number
K050223 ↗
Decision Date
February 24, 2005
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Vivawave Microwave Ablation System received FDA clearance through the 510k pathway on February 24, 2005. Manufactured by Vivant Medical, it is classified as a Class 2 medical device.
What It Is
The Vivawave Microwave Ablation System is designed to deliver microwave energy to tissue, causing thermal ablation of tumors. It works by using a coaxial introducer to guide the microwave antenna to the target tissue, where it emits energy to heat and destroy cancer cells. This minimally invasive technique offers an alternative to surgical resection, particularly for patients who are not surgical candidates.
Clinical Applications
This device is commonly used in the treatment of liver, lung, and kidney tumors. It is typically employed in interventional radiology suites or operating rooms. Patients who benefit from this technology often include those with inoperable tumors or those seeking a less invasive treatment option. The system is particularly useful in ablating tumors that are difficult to access surgically.
Indications for Use
The FDA indications for the Vivawave Microwave Ablation System include the ablation of soft tissue tumors. It is intended for patients with tumors that are accessible via percutaneous or open surgical approaches, providing a treatment option for those with limited surgical alternatives.
Practical Considerations
Clinicians should consider the size and location of the tumor when selecting the appropriate coaxial introducer and antenna. The system is compatible with imaging modalities such as ultrasound or CT for precise placement. Proper technique is essential to ensure effective ablation and minimize damage to surrounding tissues.
Frequently Asked Questions
What is the Vivawave Microwave Ablation System used for?
It is used for the thermal ablation of tumors, particularly in the liver, lung, and kidney.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device.
What are the FDA-cleared indications?
The device is cleared for the ablation of soft tissue tumors, providing a minimally invasive treatment option for patients with inoperable or difficult-to-access tumors.
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.