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stingray lp catheter
Boston Scientific
Summary: The Stingray LP Catheter is a device used in coronary interventions, specifically for re-entering the distal true lumen during chronic total occlusion procedures. Key evidence highlights its successful application in antegrade dissection and re-entry strategies.
FDA Clearance Information
Pathway
510K
Number
K152401 ↗
Decision Date
December 4, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Stingray LP Catheter was cleared by the FDA through the 510(k) pathway on December 4, 2015. It is manufactured by Boston Scientific and classified as a Class 2 device under product code DQY.
What It Is
The Stingray LP Catheter is a low-profile catheter designed for use in coronary interventions. It facilitates re-entry into the distal true lumen during chronic total occlusion procedures, aiding in the treatment of acute vessel closure.
Clinical Applications
Commonly used in percutaneous coronary interventions, the Stingray LP Catheter is employed during antegrade dissection and re-entry strategies to manage chronic total occlusions and acute vessel closures.
Evidence Summary
The available literature includes three studies: a case series and two other types, spanning from 2017 to 2019. These studies explore the device's application in coronary interventions.
Reported Outcomes
Published studies report successful use of the Stingray LP Catheter in antegrade dissection and re-entry procedures, with all cases in one study successfully using 7 Fr guiding catheters. The device facilitated good exchange and delivery without the need for balloon pre-dilatations in some cases.
Safety Profile
Reported complications include none related to access site in the studies reviewed. The device's 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 confirm the findings and explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Stingray LP Catheter?
The Stingray LP Catheter is indicated for use in coronary interventions, specifically during antegrade dissection and re-entry strategies for chronic total occlusions.
What outcomes have been reported in clinical studies?
Studies have reported successful application of the Stingray LP Catheter in antegrade dissection and re-entry procedures, with effective device delivery and minimal need for additional interventions.
What complications have been reported?
Safety data from 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.