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select 3d arterial cannula with carmeda bioactive surface and select cap arterial cannula with carmeda bioactive surface
Medtronic Perfusion Systems
Summary: The Select 3D Arterial Cannula with Carmeda Bioactive Surface is used primarily in cardiopulmonary bypass procedures. Key evidence highlights its role in reducing embolic events during surgery.
FDA Clearance Information
Pathway
510K
Number
K033416 ↗
Decision Date
November 5, 2003
Product Code
DWF
Device Class
Class 2
Evidence
0 studies
The Select 3D Arterial Cannula was cleared through the FDA 510(k) pathway on November 5, 2003. It is manufactured by Medtronic Perfusion Systems and classified as a Class 2 device.
What It Is
The Select 3D Arterial Cannula is designed for use in cardiopulmonary bypass procedures. It features a Carmeda Bioactive Surface to enhance biocompatibility and reduce thrombotic events.
Clinical Applications
This device is commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as coronary artery bypass grafting, to facilitate arterial blood flow and minimize embolic risks.
Evidence Summary
The literature includes five studies, encompassing various study designs such as RCTs and hydrodynamic analyses, conducted between 2008 and 2024.
Reported Outcomes
Published studies report that the Select 3D Arterial Cannula reduces particulate and gaseous emboli during cardiopulmonary bypass, potentially lowering the risk of neurocognitive deficits post-surgery.
Safety Profile
Reported complications include potential high-velocity flow causing strain on the aortic wall, as observed in hydrodynamic studies. No direct adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies directly linking the device to clinical outcomes. Further research is needed to confirm its efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Select 3D Arterial Cannula?
The device is indicated for use in cardiopulmonary bypass procedures to facilitate arterial blood flow.
What outcomes have been reported in clinical studies?
Studies report a reduction in embolic events during cardiopulmonary bypass, potentially improving postoperative neurocognitive outcomes.
What complications have been reported?
Safety data indicate potential high-velocity flow causing strain on the aortic wall, but no direct adverse events were 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.