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surfacer inside-out access catheter system
Merit Medical System
Summary: The Surfacer Inside-Out Access Catheter System is designed for central venous access in cases of occlusion. It is primarily used to restore access in total central vein occlusion. Key evidence highlights its effectiveness and safety in complex vascular access scenarios.
FDA Clearance Information
Pathway
510K
Number
K252527 ↗
Decision Date
September 10, 2025
Product Code
QJH
Device Class
Class 2
Evidence
0 studies
The Surfacer Inside-Out Access Catheter System was cleared by the FDA through the 510(k) pathway on September 10, 2025. It is manufactured by Merit Medical System and classified as a Class 2 medical device.
What It Is
The Surfacer Inside-Out Access Catheter System is a medical device used to gain central venous access in patients with occluded veins. It operates by creating an inside-out pathway from the femoral vein to the right internal jugular vein, facilitating catheter placement in challenging vascular conditions.
Clinical Applications
This device is commonly used in patients with chronic thoracic venous occlusion or total central vein occlusion, particularly when conventional access methods are not feasible. It is often employed in conjunction with other vascular access devices like the HeRO graft.
Evidence Summary
The literature includes a mix of case series and retrospective studies, with a total of 10 studies published between 2023 and 2025. These studies explore the device's application in complex vascular access scenarios.
Reported Outcomes
Published studies report high technical success rates and effective restoration of vascular access in patients with total central vein occlusion. One case series noted a 100% technical success rate and a mean primary patency of 199 days. The device has been shown to facilitate early cannulation and reduce intervention rates.
Safety Profile
Reported complications include potential risks associated with acute iliocaval thrombosis, which could lead to embolization. However, no significant adverse events were highlighted in the available studies, indicating a favorable safety profile.
Evidence Limitations
The current evidence is limited by the small sample sizes and the retrospective nature of many studies. Further research is needed to establish long-term outcomes and to evaluate the device's performance in a broader patient population.
Frequently Asked Questions
What are the clinical indications for Surfacer Inside-Out Access Catheter System?
The device is indicated for use in patients with total central vein occlusion, particularly when conventional access methods are not feasible.
What outcomes have been reported in clinical studies?
Studies report high technical success rates and effective restoration of vascular access, with a mean primary patency of 199 days in one case series.
What complications have been reported?
Reported complications include potential risks of acute iliocaval thrombosis, but no significant adverse events were highlighted in the studies.
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.