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vivawave microwave ablation system
Valleylab
Summary: The Vivawave Microwave Ablation System by Valleylab is a device used for tumor ablation. It is primarily used in treating unresectable lung malignancies. Key evidence highlights its efficacy in improving patient survival.
FDA Clearance Information
Pathway 510K
Number K053535 ↗
Decision Date April 27, 2006
Product Code NEY
Device Class Class 2
Evidence 0 studies
The Vivawave Microwave Ablation System was cleared by the FDA via the 510(k) pathway on April 27, 2006. It is manufactured by Valleylab and classified as a Class 2 device under product code NEY.
What It Is
The Vivawave Microwave Ablation System is a medical device designed for the ablation of tumors using microwave energy. It is intended for use in clinical settings to treat solid organ tumors, particularly when surgical resection is not feasible.
Clinical Applications
Common clinical scenarios for the Vivawave system include the treatment of unresectable lung malignancies. It is used in settings where traditional surgical options are limited or not possible.
Evidence Summary
The available literature includes two studies: a retrospective study on lung malignancies and a guideline study on power and time variables for microwave ablation. These studies span from 2009 to 2013.
Reported Outcomes
Published studies report that the Vivawave Microwave Ablation System is effective in improving survival rates in patients with unresectable lung malignancies. The retrospective study highlights its efficacy in a cohort of 56 patients.
Safety Profile
Reported complications include those associated with percutaneous CT-guided microwave ablation, as noted in the retrospective study. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of the primary study. Further research is needed to establish long-term outcomes and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Vivawave Microwave Ablation System?
The device is indicated for the ablation of tumors, particularly in cases of unresectable lung malignancies.
What outcomes have been reported in clinical studies?
Studies have reported improved survival rates in patients with unresectable lung malignancies treated with the device.
What complications have been reported?
Complications related to percutaneous CT-guided microwave ablation have been reported, though specific adverse events were not detailed.
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.