📊 Evidence-Based Reference
Vera 103
Madsen North America
Summary: The vera 103 is an ablation device for tumor treatment, manufactured by Madsen North America. It was FDA 510k cleared in 1990. Key evidence includes 14 studies, focusing on outcomes and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K897143 ↗
Decision Date ?
April 27, 1990
Product Code ?
LYN
Device Class ?
Class 2
Evidence ?
0 studies
The vera 103 was cleared through the FDA 510k pathway on April 27, 1990. It is manufactured by Madsen North America and classified as a Class 2 device under product code LYN.
What It Is
The vera 103 is a medical device designed for tumor ablation. It utilizes energy to destroy cancerous tissues and is intended for use in oncological procedures. The device is specifically engineered for precision in targeting tumor cells.
FDA-Cleared Indications
- Ablation of tumor tissue in oncological procedures, according to the available device description.
Clinical Applications
- Tumor ablation when treatment is performed under the device's FDA-cleared labeling.
- Destruction of targeted cancerous tissue during an oncology procedure.
- Use as a minimally invasive tumor-treatment option when the treating team determines that surgical resection is not feasible.
Evidence Summary
The available literature includes 14 studies, comprising randomized controlled trials and observational studies, conducted between 2021 and 2025. These studies explore the efficacy and safety of the vera 103 in clinical applications.
Reported Outcomes
Published studies report varied outcomes, with some focusing on the efficacy of tumor ablation and others on the device's role in managing specific conditions like polycythemia vera. Notably, one study highlighted a 56% response rate in cytomegalovirus DNA clearance with maribavir therapy.
Safety Profile
Reported complications include general adverse events associated with ablation procedures, though specific safety data for the vera 103 is limited in the provided studies. Further research is needed to comprehensively assess the safety profile.
Evidence Limitations
The evidence base for the vera 103 is limited by a lack of direct studies on the device itself, with much of the literature focusing on related conditions or alternative therapies. Further research is needed to establish comprehensive efficacy and safety data.
Practical Considerations
- The available record does not specify the device's energy modality, applicator design, dimensions, or treatment settings; clinicians should consult the original FDA clearance and current manufacturer labeling.
- Compatibility with generators, probes, grounding pads, imaging systems, and other accessories should be confirmed before use.
- MRI safety is not established by the information provided. Do not assume the device or its accessories are MR Safe or MR Conditional without manufacturer documentation.
- Contraindications, anticoagulation requirements, anesthesia needs, and protection of nearby organs depend on the treatment system and tumor location.
- Ablation should be performed with appropriate imaging guidance and monitoring by clinicians trained in the applicable tumor-ablation technique.
Frequently Asked Questions
What are the clinical indications for vera 103?
The vera 103 is indicated for tumor ablation, as per FDA documentation. It is used in oncological procedures where surgical options are limited.
What outcomes have been reported in clinical studies?
Specific findings include a 56% response rate in cytomegalovirus DNA clearance with maribavir therapy, though direct outcomes for vera 103 are not detailed.
What complications have been reported?
Reported complications include general adverse events typical of ablation procedures, but specific safety data for vera 103 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.