Medtronic received FDA 510(k) clearance to market its Aquamantys SBS 5.0 Sheathed Bipolar Sealer for sealing soft tissue and epidural veins during spinal surgery.
The device delivers RF energy for cauterization and saline to keep the area clean and clear for easy access around sensitive tissue.
From the press release:
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.
“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 Dr. Paul Santiago, a surgeon at Washington University School of Medicine. “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.”
Press release: Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery