đź“‹ FDA Reference
sorin biomedica smarxt bcd vanguard surface modified cardioplegia system
Cobe Cardiovascular
Summary: The Sorin Biomedica Smarxt BCD Vanguard is a surface-modified cardioplegia system used in cardiac surgeries to protect the heart muscle. It is primarily used by cardiac surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K021830 ↗
Decision Date
July 2, 2002
Product Code
DTR
Device Class
Class 2
Evidence
0 studies
The Sorin Biomedica Smarxt BCD Vanguard was cleared through the FDA 510(k) pathway on July 2, 2002. It is manufactured by Cobe Cardiovascular and classified as a Class 2 device under product code DTR.
What It Is
The Sorin Biomedica Smarxt BCD Vanguard is a specialized system designed to deliver cardioplegia solutions during cardiac surgery. Cardioplegia is a technique used to intentionally and temporarily stop the heart to provide a still and bloodless field for the surgeon. This device modifies the surface to enhance the delivery and effectiveness of the cardioplegia solution, ensuring optimal myocardial protection during procedures.
Clinical Applications
This device is commonly used in open-heart surgeries, including coronary artery bypass grafting (CABG) and valve replacements. It is utilized in operating rooms by cardiac surgeons to manage myocardial protection. The system is particularly beneficial in procedures where prolonged cardiac arrest is necessary, and it is suitable for adult and pediatric cardiac surgery patients.
Indications for Use
The FDA indications suggest that this device is used for myocardial protection during cardiac surgeries. It is specifically designed for patients undergoing procedures that require the heart to be temporarily stopped.
Practical Considerations
The Sorin Biomedica Smarxt BCD Vanguard is compatible with standard cardioplegia delivery systems. Clinicians should ensure proper integration with existing surgical setups and verify compatibility with the cardioplegia solutions used in their practice.
Frequently Asked Questions
What is Sorin Biomedica Smarxt BCD Vanguard used for?
It is used to deliver cardioplegia solutions during cardiac surgeries to protect the heart muscle.
What specialties typically use this device?
Cardiac surgeons in hospital operating rooms typically use this device.
What are the FDA-cleared indications?
It is indicated for myocardial protection during cardiac surgeries that require the heart to be temporarily stopped.
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.