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bridgepoint medical crossboss percutaneous coronary catheter
Bridgepoint Medical
Summary: The BridgePoint Medical CrossBoss Percutaneous Coronary Catheter is designed for crossing chronic total occlusions in coronary arteries. It is primarily used in percutaneous coronary interventions. Key evidence highlights its efficacy in crossing occlusions with a high success rate.
FDA Clearance Information
Pathway
510K
Number
K081130 ↗
Decision Date
May 14, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CrossBoss catheter was cleared by the FDA through the 510(k) pathway on May 14, 2009. It is manufactured by Bridgepoint Medical and classified as a Class 2 medical device.
What It Is
The CrossBoss catheter is a percutaneous coronary device used to facilitate the crossing of chronic total occlusions (CTOs) in coronary arteries. It is designed to navigate through occluded vessels, allowing for subsequent revascularization procedures.
Clinical Applications
The device is commonly used in interventional cardiology for patients with coronary CTOs, particularly in cases of in-stent restenosis. It is employed to improve the success rates of percutaneous coronary interventions by enabling access to the distal true lumen.
Evidence Summary
The available literature includes a systematic review and several case series, with studies conducted between 2012 and 2020. The evidence base consists of approximately 5 studies, highlighting the device's application in coronary interventions.
Reported Outcomes
Published studies report that the CrossBoss catheter has a high success rate in crossing coronary chronic total occlusions, with one study noting successful crossing in 83% of cases. The device has been shown to facilitate revascularization in complex coronary lesions, including those with in-stent restenosis.
Safety Profile
Reported complications include the potential for the catheter to exit through stent struts into the subintimal space, as noted in one case study. However, no significant adverse events were reported in the majority of studies reviewed.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term outcome data. Further research is needed to assess the long-term safety and efficacy of the CrossBoss catheter in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for BridgePoint Medical CrossBoss Percutaneous Coronary Catheter?
The device is indicated for use in crossing chronic total occlusions in coronary arteries, particularly in cases of in-stent restenosis.
What outcomes have been reported in clinical studies?
Studies report a high success rate in crossing coronary chronic total occlusions, with successful crossing in 83% of cases in one study.
What complications have been reported?
Reported complications include the potential for the catheter to exit through stent struts into the subintimal space, though no significant adverse events were noted in most 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.