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sorin biomedica smart bcd vanguard surface modified blood cardioplegia system
Cobe Cardiovascular
Summary: The Sorin Biomedica Smart BCD Vanguard is a surface-modified blood cardioplegia system used in cardiac surgeries to protect the heart muscle. It is primarily used by cardiac surgeons and perfusionists during open-heart procedures.
FDA Clearance Information
Pathway
510K
Number
K012763 ↗
Decision Date
November 15, 2001
Product Code
DRT
Device Class
Class 2
Evidence
0 studies
The Sorin Biomedica Smart BCD Vanguard was cleared through the FDA 510(k) pathway on November 15, 2001. Manufactured by Cobe Cardiovascular, it is classified as a Class 2 device under product code DRT.
What It Is
The Sorin Biomedica Smart BCD Vanguard is a specialized system designed to deliver cardioplegia solution to the heart during cardiac surgery. Cardioplegia is a technique used to induce cardiac arrest, providing a motionless field and protecting the heart muscle during surgery. The device's surface modification aims to enhance biocompatibility and reduce potential complications associated with blood contact surfaces.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures such as coronary artery bypass grafting (CABG) and valve replacements. It is utilized by cardiac surgeons and perfusionists to ensure effective myocardial protection. The device is suitable for adult and pediatric patients undergoing open-heart surgery, where precise delivery of cardioplegia is critical.
Indications for Use
The FDA indications suggest that this device is intended for use in delivering cardioplegia solution during cardiac surgeries. It is specifically designed for patients undergoing procedures that require temporary cardiac arrest to protect the heart muscle.
Practical Considerations
The Sorin Biomedica Smart BCD Vanguard is typically compatible with standard cardiopulmonary bypass systems. Clinicians should ensure proper setup and priming of the device to maintain optimal performance. Familiarity with the device's operation and integration into the surgical workflow is essential for effective use.
Frequently Asked Questions
What is the Sorin Biomedica Smart BCD Vanguard used for?
It is used to deliver cardioplegia solution during cardiac surgeries to protect the heart muscle.
What specialties typically use this device?
Cardiac surgeons and perfusionists in cardiac surgery settings typically use this device.
What are the FDA-cleared indications?
It is indicated for use in delivering cardioplegia solution during cardiac surgeries requiring temporary cardiac arrest.
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.