FDA clears Aquamantys SBS 5.0 sheathed bipolar sealer for spine surgery


The US Food and Drug Administration FDA has given 510(k) clearance to Medtronic for its Aquamantys SBS 5.0 sheathed bipolar sealer used in spine surgery.

The sealer gives spine surgeons the ability to optimise speed and continuity in surgical cases by providing haemostatic sealing capabilities for both incised soft tissue and epidural veins with a single device.


The SBS 5.0 uses Transcollation technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualisation when used during spine procedures.


“The SBS 5.0 is a great combination tool that will allow surgeons to treat cut muscle planes as well as compress and treat epidural veins with a single device,” said Paul Santiago, Washington University School of Medicine, USA. “This will be particularly useful in cases like 1– 2 level TLIFs/PLIFs in which you want the ability to address both of these needs but the economics can make using multiple devices difficult.”