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outback catheter
Lumend
Summary: The Outback Catheter is a reentry device used in subintimal angioplasty for chronic total occlusions. It is primarily used when conventional techniques fail. Key evidence highlights its utility in complex arterial recanalizations.
FDA Clearance Information
Pathway
510K
Number
K001577 ↗
Decision Date
January 11, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Outback Catheter was cleared by the FDA through the 510(k) pathway on January 11, 2001. It is manufactured by Lumend and classified as a Class 2 device.
What It Is
The Outback Catheter is a reentry device designed to facilitate reentry into the true lumen of a vessel during subintimal angioplasty. It is intended for use in cases of chronic total occlusions where traditional wire and catheter techniques are unsuccessful.
Clinical Applications
Commonly used in the recanalization of iliac and femoro-popliteal arteries, the Outback Catheter is also applied in challenging cases involving tibio-peroneal and infragenicular arteries. It is particularly useful in retrograde recanalizations.
Evidence Summary
The literature includes 13 studies, comprising retrospective evaluations and case series, published between 2016 and 2023. These studies explore the catheter's application in various arterial occlusions.
Reported Outcomes
Published studies report that the Outback Catheter significantly aids in achieving successful reentry in complex arterial occlusions. It has been shown to improve procedural success rates in cases where conventional methods fail.
Safety Profile
Reported complications include potential vessel injury during reentry and procedural challenges in certain anatomical locations. However, specific adverse events are not extensively detailed in the available studies.
Evidence Limitations
The evidence is primarily retrospective and lacks large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and safety profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Outback Catheter?
The Outback Catheter is indicated for use in subintimal angioplasty for chronic total occlusions, particularly when conventional reentry techniques are unsuccessful.
What outcomes have been reported in clinical studies?
Studies report improved success rates in achieving reentry in complex arterial occlusions, particularly in infrainguinal and tibio-peroneal arteries.
What complications have been reported?
Reported complications include potential vessel injury during reentry, though specific adverse events are not extensively 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.