Medtronic, Inc. Announces 510 Clearance For Aquamantys SBS 5.0 Sheathed Bipolar Sealer For Spine Surgery
Medtronic, Inc. announced that it has received 510 clearance from the Food and Drug Administration (FDA) for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the Company’s Advanced Energy business. The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time.
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