📊 Evidence-Based Reference
Vascular Access Port Catheter No Vp-Xxx Vasport
Gish Biomedical
Summary: The vascular access port catheter no vp-xxx vasport by Gish Biomedical is a device used for venous access, primarily in chemotherapy and long-term intravenous therapy. Key evidence highlights its use in reducing complications compared to other devices.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K882969 ↗
Decision Date ?
September 26, 1988
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA through the 510(k) pathway on September 26, 1988. It is manufactured by Gish Biomedical and classified as a Class 2 medical device.
What It Is
The vascular access port catheter is a totally implantable device designed for repeated access to the venous system. It is used in clinical settings for patients requiring long-term intravenous therapy, such as chemotherapy.
FDA-Cleared Indications
- Long-term or repeated access to the venous system for administration of intravenous therapy.
- Venous access for patients requiring repeated infusion or blood sampling.
Clinical Applications
- Administration of chemotherapy through an implanted venous port.
- Administration of other long-term intravenous therapies.
- Parenteral nutrition when durable venous access is required.
- Repeated blood sampling through an implanted venous access device.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective, and retrospective studies, published between 2020 and 2024. These studies explore various aspects of device efficacy and safety.
Reported Outcomes
Published studies report that the vascular access port catheter is effective in reducing complications associated with venous access in cancer patients. It is shown to be cost-effective and clinically acceptable compared to other central venous access devices.
Safety Profile
Reported complications include infection, device malfunction, and premature removal due to complications. However, the infection rates are comparable to those reported in the literature.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term follow-up data. Further research is needed to explore the device's performance in diverse patient populations.
Practical Considerations
- The port is implanted beneath the skin, with the catheter tip positioned in a central vein; it is accessed with a non-coring needle.
- Available dimensions and catheter configurations depend on the specific product labeling and should be matched to the patient, treatment, and venous anatomy.
- Use only compatible infusion solutions, syringes, needles, and flushing protocols specified by the device labeling and institutional policy.
- MRI safety depends on the exact port and catheter components; confirm the device's current MRI labeling before scanning.
- Potential complications include infection, catheter occlusion, thrombosis, malposition, leakage, vessel injury, and mechanical damage. The device may be unsuitable when venous access is not feasible or when active infection is present.
Frequently Asked Questions
What are the clinical indications for vascular access port catheter no vp-xxx vasport?
The device is indicated for patients requiring long-term venous access, such as those undergoing chemotherapy or parenteral nutrition.
What outcomes have been reported in clinical studies?
Studies have reported reduced complication rates and cost-effectiveness compared to other central venous access devices.
What complications have been reported?
Safety data indicate complications such as infection and device malfunction, with infection rates comparable to existing literature.
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.