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bridgepoint medical stingray device and accessories
Bridgepoint Medical
Summary: The BridgePoint Medical Stingray device is used for crossing chronic total occlusions in coronary and peripheral arteries. Key evidence highlights its role in improving procedural success rates.
FDA Clearance Information
Pathway
510K
Number
K080987 ↗
Decision Date
February 6, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The BridgePoint Medical Stingray device was cleared by the FDA through the 510(k) pathway on February 6, 2009. It is manufactured by Bridgepoint Medical and classified as a Class 2 device.
What It Is
The BridgePoint Medical Stingray device is designed to facilitate the crossing of chronic total occlusions (CTOs) in coronary and peripheral arteries. It employs a re-entry system to navigate and re-enter the true lumen of occluded vessels.
Clinical Applications
The device is commonly used in percutaneous coronary interventions (PCI) for patients with CTOs, particularly when traditional wire-based techniques fail to re-enter the true lumen. It is also applied in complex peripheral artery occlusions.
Evidence Summary
The available literature includes a mix of randomized controlled trials, prospective and retrospective studies, and case series, with a total of 5 studies published between 2011 and 2016.
Reported Outcomes
Published studies report that the BridgePoint Medical Stingray device improves success rates in crossing coronary and peripheral CTOs. Long-term outcomes are not extensively documented, but initial success in re-entering the true lumen is noted.
Safety Profile
Reported complications include technical failures related to the inability to re-enter the true lumen in some cases. However, specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of long-term outcome data and detailed safety profiles. Further research is needed to establish comprehensive efficacy and safety metrics.
Frequently Asked Questions
What are the clinical indications for BridgePoint Medical Stingray device?
The device is indicated for use in crossing chronic total occlusions in coronary and peripheral arteries, particularly when traditional methods are unsuccessful.
What outcomes have been reported in clinical studies?
Studies report improved success rates in crossing CTOs, but long-term outcomes are not well-documented.
What complications have been reported?
Reported complications include technical failures in re-entering the true lumen, though specific adverse events are not detailed.
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.