đź“Š Evidence-Based Reference
surfacer inside-out access catheter system
Bluegrass Vascular Technologies
Summary: The Surfacer Inside-Out Access Catheter System is a device designed for central venous access in patients with occluded veins. It is primarily used in cases of thoracic central vein occlusion. Key evidence highlights its effectiveness in restoring vascular access with high technical success rates.
FDA Clearance Information
Pathway
510K
Number
DEN190038 ↗
Decision Date
February 10, 2020
Product Code
QJH
Device Class
Class 2
Evidence
0 studies
The Surfacer Inside-Out Access Catheter System was cleared by the FDA via the 510(k) pathway on February 10, 2020. It is manufactured by Bluegrass Vascular Technologies and is classified as a Class 2 device.
What It Is
The Surfacer Inside-Out Access Catheter System is a medical device used to facilitate central venous access in patients with occluded veins. It operates by creating a pathway from the inside of the vein to the outside, allowing for catheter placement in challenging cases.
Clinical Applications
This device is commonly used in patients with thoracic central vein occlusion, particularly when conventional vascular access methods are not feasible. It is often employed in conjunction with other devices like the HeRO graft for dialysis access.
Evidence Summary
The available literature includes a mix of case reports and series, with approximately 10 studies published between 2023 and 2025. These studies explore the device's use in various clinical scenarios, focusing on its efficacy and safety.
Reported Outcomes
Published studies report high technical success rates for the Surfacer Inside-Out Access Catheter System, with some studies noting a 100% success rate in achieving vascular access. Mean operating times and primary patency durations vary, but early cannulation is typically achieved within a few days. The device has been shown to effectively restore access in patients with total central vein occlusion.
Safety Profile
Reported complications include potential risks associated with the procedure, such as embolization in cases of acute iliocaval thrombosis. However, specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence is primarily composed of case reports and series, which may limit the generalizability of findings. Further research is needed to establish long-term safety and efficacy, as well as to explore outcomes in larger, more diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Surfacer Inside-Out Access Catheter System?
The device is indicated for use in patients with thoracic central vein occlusion where conventional vascular access methods are not feasible.
What outcomes have been reported in clinical studies?
Studies report high technical success rates, with early cannulation typically achieved within a few days and primary patency lasting several months.
What complications have been reported?
Reported complications include risks of embolization in acute iliocaval thrombosis, though specific adverse events are not detailed in the evidence provided.
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.