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solcotrans orthopaedic drainage reinfusion system
Solco Basle
Summary: The Solcotrans Orthopaedic Drainage Reinfusion System is used for postoperative blood salvage in total joint arthroplasty. Key evidence shows reduced need for transfusions.
FDA Clearance Information
Pathway
510K
Number
K896857 ↗
Decision Date
April 5, 1990
Product Code
CAC
Device Class
Class 2
Evidence
0 studies
The Solcotrans Orthopaedic Drainage Reinfusion System was cleared by the FDA via the 510(k) pathway on April 5, 1990. It is manufactured by Solco Basle and classified as a Class 2 device.
What It Is
The Solcotrans Orthopaedic Drainage Reinfusion System is designed to collect and reinfuse autologous blood during the postoperative period in orthopaedic surgeries, particularly total joint arthroplasty. It aims to reduce the need for allogeneic blood transfusions.
Clinical Applications
This device is commonly used in elective total joint arthroplasty procedures to manage postoperative blood loss. It is particularly beneficial in scenarios where minimizing allogeneic blood transfusion is desired.
Evidence Summary
The available literature includes two studies conducted in the early 1990s. These studies are prospective and randomized, involving a total of 83 patients, and focus on the efficacy of the Solcotrans system in reducing transfusion needs.
Reported Outcomes
Published studies report that the use of the Solcotrans system significantly reduces the need for postoperative blood transfusions in total joint arthroplasty. One study found that only 25% of patients required transfusions compared to 83% in the control group. In total knee arthroplasties, the need for transfusions was reduced to 11% in the study group.
Safety Profile
Reported complications include the general risks associated with postoperative blood salvage systems, although specific adverse events were not detailed in the provided studies. Overall, the system is considered safe when used as intended.
Evidence Limitations
The evidence is limited to two studies from the early 1990s, with small sample sizes and a narrow focus on total joint arthroplasty. Further research is needed to evaluate long-term outcomes and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Solcotrans Orthopaedic Drainage Reinfusion System?
The device is indicated for use in postoperative blood salvage during total joint arthroplasty to reduce the need for allogeneic blood transfusions.
What outcomes have been reported in clinical studies?
Studies report a significant reduction in the need for postoperative blood transfusions, with only 25% of patients requiring transfusions compared to 83% in the control group.
What complications have been reported?
Reported complications include general risks associated with blood salvage systems, though specific adverse events were not detailed in the studies.
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.