📊 Evidence-Based Reference
Extracorporeal Circuit with Bio-Active Surface
Medtronic Blood Systems
Summary: The extracorporeal circuit with bio-active surface by Medtronic is used primarily in cardiopulmonary bypass procedures. Key evidence highlights its impact on hematological indices and myocardial dysfunction markers.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K891687 ↗
Decision Date ?
May 31, 1989
Product Code ?
DTZ
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA through the 510(k) pathway on May 31, 1989. It is manufactured by Medtronic Blood Systems and classified as a Class 2 device.
What It Is
This device is an extracorporeal circuit with a bio-active surface designed to reduce blood activation and improve biocompatibility during procedures like cardiopulmonary bypass. It is intended to minimize complications associated with blood contact with foreign surfaces.
FDA-Cleared Indications
- Use as an extracorporeal blood circuit during procedures requiring cardiopulmonary bypass.
- Use for circulating blood outside the body while supporting extracorporeal cardiac and pulmonary function.
- Use with compatible extracorporeal circulation equipment according to the manufacturer's labeling.
Clinical Applications
- Cardiopulmonary bypass during open-heart surgery.
- Extracorporeal circulation during aortocoronary bypass grafting.
- Blood circulation through a cardiac surgery heart-lung machine.
- Support of extracorporeal cardiac and pulmonary circulation when used as part of a compatible labeled system.
Evidence Summary
The literature includes 8 studies, comprising randomized controlled trials and prospective studies, conducted between 1994 and 2003. These studies investigate the device's impact on hematological parameters and organ dysfunction markers.
Reported Outcomes
Published studies report that the device affects C5a concentration and leukocyte counts, with increased granulocytes and leukocytes observed. The device also maintains high levels of free hemoglobin in autotransfused blood, indicating its influence on blood parameters during extracorporeal circulation.
Safety Profile
Reported complications include increased levels of free hemoglobin and elevated leukocyte counts, which may indicate an inflammatory response. No severe adverse events directly attributed to the device were noted in the studies.
Evidence Limitations
The evidence is limited by small sample sizes and a focus on specific patient populations. Further research is needed to explore long-term outcomes and broader clinical applications.
Practical Considerations
- The circuit must be selected for compatibility with the heart-lung machine, oxygenator, pumps, connectors and other extracorporeal components.
- Circuit configuration and tubing dimensions vary by patient size, flow requirements and the intended procedure; use the manufacturer's specifications for component selection.
- The circuit requires priming, de-airing and handling by trained cardiopulmonary bypass or extracorporeal-circulation personnel.
- This is a blood-contacting, single-use device; anticoagulation and monitoring are managed according to the operative protocol and the patient's condition.
- MRI safety depends on the complete circuit and any connected components. An extracorporeal circuit should not be taken into an MRI environment unless its labeling specifically permits it.
Frequently Asked Questions
What are the clinical indications for extracorporeal circuit with bio-active surface?
The device is indicated for use in cardiopulmonary bypass procedures and ECMO support in cases of cardiogenic shock.
What outcomes have been reported in clinical studies?
Studies report effects on C5a concentration, granulocyte and leukocyte counts, and free hemoglobin levels during extracorporeal circulation.
What complications have been reported?
Reported complications include increased free hemoglobin and elevated leukocyte counts, suggesting potential inflammatory responses.
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.