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stingray lp catheter
Boston Scientific
Summary: The Stingray LP catheter is a low-profile device used in coronary interventions, particularly for re-entering the true lumen in chronic total occlusions. Key evidence highlights its successful application in antegrade dissection re-entry strategies.
FDA Clearance Information
Pathway
510K
Number
K231176 ↗
Decision Date
May 25, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Stingray LP catheter by Boston Scientific was cleared via the FDA 510(k) pathway on May 25, 2023. It is classified as a Class 2 device under product code DQY.
What It Is
The Stingray LP catheter is designed for use in coronary interventions, specifically to aid in re-entering the true lumen during chronic total occlusion procedures. It facilitates precise guidewire placement in challenging vascular scenarios.
Clinical Applications
Commonly used in percutaneous coronary interventions, the Stingray LP catheter is employed in scenarios involving chronic total occlusions where traditional guidewire techniques are insufficient. It is particularly useful in antegrade dissection re-entry strategies.
Evidence Summary
The literature includes three studies, comprising case series and other types, published between 2017 and 2019. These studies explore the catheter's application in coronary interventions, focusing on its efficacy and safety.
Reported Outcomes
Published studies report successful use of the Stingray LP catheter in antegrade dissection re-entry procedures, with all cases in one study successfully utilizing 7 Fr guiding catheters. The device facilitated smooth puncture into the true lumen and eliminated the need for balloon pre-dilatations in some cases.
Safety Profile
Reported complications include no access site-related issues in the studies reviewed. The device's low-profile design minimizes the risk of complications associated with larger guiding catheters.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to validate findings across diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for Stingray LP catheter?
The Stingray LP catheter is indicated for use in coronary interventions, particularly in chronic total occlusion procedures to facilitate re-entry into the true lumen.
What outcomes have been reported in clinical studies?
Studies have reported successful application of the Stingray LP catheter in antegrade dissection re-entry strategies, with effective guidewire placement and no need for balloon pre-dilatations in some cases.
What complications have been reported?
Safety data from the evidence indicates no access site-related complications were reported in the reviewed 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.