📊 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 ?
510(k)
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.
FDA-Cleared Indications
- Establishing central venous access in patients with thoracic central venous occlusion or obstruction.
- Creating an inside-out access route when conventional central venous access is not feasible or has failed.
Clinical Applications
- Central venous access in patients with occlusion of the thoracic central veins.
- Creation of a wire pathway from the central venous system to the skin for subsequent catheter placement.
- Use during placement of long-term central venous access devices when standard access routes are unavailable.
- Use as part of an access strategy for patients requiring hemodialysis access, including cases in which a HeRO graft may be considered.
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.
Practical Considerations
- The system is intended for use by trained clinicians with fluoroscopic imaging and venography or other appropriate imaging to define the venous anatomy.
- The device is used through vascular access sheaths and must be compatible with the planned guidewire, catheter, or dialysis-access procedure.
- Careful assessment is needed for central venous anatomy, chronic thrombus, collateral vessels, infection, bleeding risk, and the ability to safely puncture toward the chest wall.
- Device dimensions, sheath requirements, and available components should be confirmed in the current manufacturer instructions for use before the procedure.
- MRI safety and conditions depend on the specific device components and whether any implanted catheter or graft remains in place; consult the current labeling and implant documentation.
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.