Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
Bioptimal International Pte. , Ltd.
FDA Clearance Information
FDA-Cleared Indications
- Used for intravascular diagnostic monitoring of cardiac and pulmonary artery pressures.
- Used to obtain hemodynamic measurements during the diagnosis and management of cardiovascular conditions.
- Intended for use by qualified healthcare professionals in appropriate clinical settings.
Clinical Applications
- Pulmonary artery pressure monitoring.
- Right-heart catheterization and hemodynamic assessment.
- Measurement of right-sided cardiac pressures and related cardiovascular parameters.
- Hemodynamic monitoring in patients who require invasive cardiovascular assessment.
Practical Considerations
- The listed models represent different catheter configurations, lengths and connector or monitoring options; the exact specifications should be confirmed in the current manufacturer labeling.
- The catheter is introduced through a central venous access site, commonly the internal jugular, subclavian or femoral vein, and advanced into the right heart and pulmonary artery under fluoroscopic or other appropriate imaging guidance.
- Use requires compatible pressure-monitoring equipment, sterile technique and trained personnel familiar with right-heart catheterization.
- Potential complications include bleeding, infection, arrhythmia, vascular injury, pulmonary artery injury, thrombosis, air embolism and catheter-related complications.
- MRI compatibility should not be assumed from the FDA clearance. Confirm the exact model's MRI labeling and conditions before an MRI examination.
Procedures that use this device
Frequently Asked Questions
What is the Bioptimal Pulmonary Artery Monitoring Catheter used for?
It is used for temporary invasive measurement of pulmonary artery, right-heart and related cardiovascular pressures during hemodynamic assessment.
Is the Bioptimal Pulmonary Artery Monitoring Catheter MRI safe?
MRI safety depends on the exact catheter model and its labeling. Do not use it in an MRI environment unless the manufacturer identifies that specific model as MR Safe or MR Conditional and all conditions are met.
What sizes does the Bioptimal Pulmonary Artery Monitoring Catheter come in?
The device is available in multiple model configurations, including TD2502 and TD2602 variants with different lengths and features. The current package labeling should be checked for French size, length, lumen configuration and connector details.
How long does a pulmonary artery monitoring catheter stay in?
It is intended for temporary use, with the duration determined by the patient's monitoring needs and the treating team. It should be removed when invasive monitoring is no longer clinically necessary or if complications occur.
How much does a Bioptimal Pulmonary Artery Monitoring Catheter cost?
The price is not generally published as a fixed retail amount. Cost varies by model, hospital or supply contract, procedure setting and insurance coverage.