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upstream goback crossing catheter
Upstream Peripheral Technologies
Summary: The Upstream GoBack Crossing Catheter is a device used for crossing chronic total occlusions in vascular interventions. It is primarily used in complex revascularizations and has demonstrated technical success in challenging cases.
FDA Clearance Information
Pathway
510K
Number
K182937 ↗
Decision Date
May 23, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Upstream GoBack Crossing Catheter was cleared via the FDA 510(k) pathway on May 23, 2019. Manufactured by Upstream Peripheral Technologies, it is classified as a Class 2 medical device.
What It Is
The Upstream GoBack Crossing Catheter is designed to facilitate the crossing of chronic total occlusions in vascular procedures. It is intended for use in revascularization of occluded vessels, particularly in the lower limbs.
Clinical Applications
This device is commonly used in scenarios where conventional crossing techniques have failed, such as chronic limb-threatening ischemia and chronic occlusive ilio-caval thrombosis. It provides a minimally invasive option for recanalization.
Evidence Summary
The available literature includes a mix of case reports, case series, and retrospective studies, with a total of 5 studies published between 2021 and 2025. These studies explore the device's utility in various clinical settings.
Reported Outcomes
Published studies report successful crossing of complex chronic total occlusions in lower limb arteries and chronic occlusive ilio-caval thrombosis. The device has shown technical success in recanalization procedures where conventional methods were inadequate.
Safety Profile
Reported complications include the typical risks associated with endovascular procedures, although specific adverse events were not detailed in the provided studies. Further safety data would be beneficial.
Evidence Limitations
The evidence is limited by the small number of studies and the predominance of case reports and series. Larger, controlled studies are needed to better understand the device's efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for Upstream GoBack Crossing Catheter?
The device is indicated for crossing chronic total occlusions in vascular interventions, particularly in cases of chronic limb-threatening ischemia and chronic occlusive ilio-caval thrombosis.
What outcomes have been reported in clinical studies?
Studies have reported successful recanalization of occluded vessels, with technical success in cases where conventional methods failed.
What complications have been reported?
Reported complications include general risks associated with endovascular procedures, but specific adverse events were not detailed 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.