đź“Š Evidence-Based Reference
closed chest support circuit w bio-active surface
Medtronic Vascular
Summary: The closed chest support circuit with bio-active surface by Medtronic Vascular is a device used in tumor ablation procedures. It was FDA-cleared via the 510(k) pathway in 1990. Key evidence includes studies on heat dissipation and arterial monitoring.
FDA Clearance Information
Pathway
510K
Number
K896978 ↗
Decision Date
February 28, 1990
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA via the 510(k) pathway on February 28, 1990. It is manufactured by Medtronic Vascular and classified as a Class 2 device under product code DTZ.
What It Is
The closed chest support circuit with bio-active surface is designed to assist in tumor ablation procedures by providing a controlled environment for heat dissipation and support. It is intended for use in clinical settings where precise thermal management is required.
Clinical Applications
This device is commonly used in scenarios requiring tumor ablation, particularly in cases where maintaining a stable thermal environment is critical. It is utilized in both military and civilian medical settings for trauma and other related procedures.
Evidence Summary
The available literature includes three studies: one RCT on arterial monitoring in swine, an in vitro study on heat dissipation, and a clinical trial on community ambulation post-hip fracture. The studies span from 1998 to 2024.
Reported Outcomes
Published studies report that the device effectively manages heat dissipation during procedures, with one study demonstrating its application in an artificial heart model. Another study validated its use in arterial monitoring during REBOA procedures, highlighting its potential in trauma care.
Safety Profile
Reported complications include potential heat transfer to surrounding tissues, as indicated in the in vitro study. No specific adverse events were detailed in the available literature, suggesting a need for further safety evaluations.
Evidence Limitations
The evidence is limited by the small number of studies and lack of comprehensive safety data. Further research is needed to explore long-term outcomes and potential complications in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for closed chest support circuit w bio-active surface?
The device is indicated for use in tumor ablation procedures, particularly where precise thermal management is required.
What outcomes have been reported in clinical studies?
Studies have reported effective heat dissipation and potential use in arterial monitoring during REBOA procedures.
What complications have been reported?
Reported complications include potential heat transfer to surrounding tissues, 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.