📋 FDA Reference
Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator
Cobe Cardiovascular
Summary: The Cobe Smarxt Optima XP is a hollow fiber membrane oxygenator used in cardiopulmonary bypass procedures. It is utilized by cardiovascular surgeons and perfusionists to oxygenate blood during surgery.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K000255 ↗
Decision Date ?
April 25, 2000
Product Code ?
DTZ
Device Class ?
Class 2
Evidence ?
0 studies
The Cobe Smarxt Optima XP was cleared through the FDA 510(k) pathway on April 25, 2000. Manufactured by Cobe Cardiovascular, it is classified as a Class 2 medical device.
What It Is
The Cobe Smarxt Optima XP is a surface-modified hollow fiber membrane oxygenator designed for use in cardiopulmonary bypass procedures. It functions by facilitating the exchange of oxygen and carbon dioxide in the blood, effectively acting as an artificial lung during surgery. The device's hollow fiber technology allows for efficient gas transfer while minimizing blood trauma.
FDA-Cleared Indications
- Use during procedures requiring cardiopulmonary bypass and extracorporeal circulation.
- Temporary oxygenation of blood and removal of carbon dioxide during cardiac surgery.
Clinical Applications
- Cardiopulmonary bypass during coronary artery bypass grafting.
- Cardiopulmonary bypass during heart valve surgery.
- Extracorporeal circulation support during other cardiac procedures requiring temporary blood-gas exchange.
Practical Considerations
- The oxygenator is used by a trained perfusion team as part of a compatible cardiopulmonary bypass circuit.
- Clinicians select the appropriate device size and circuit configuration for the patient and procedure.
- The circuit must be correctly primed and de-aired before use, with careful monitoring for leaks, air, pressure changes and inadequate gas exchange.
- This is a single-use extracorporeal device used during surgery; it is not an implant and is not intended for long-term support.
- MRI compatibility is generally not relevant while the device is connected to a cardiopulmonary bypass circuit. The labeling and institutional policy should be reviewed before exposure to an MRI environment.
Frequently Asked Questions
What is the Cobe Smarxt Optima XP used for?
It is used to oxygenate blood and remove carbon dioxide during cardiopulmonary bypass in cardiac surgeries.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists in cardiac surgery settings use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures requiring temporary blood oxygenation and carbon dioxide removal.
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.