FDA grants 510(k) clearance for Medtronic's Aquamantys SBS 5.0 Sheathed Bipolar Sealer

Medtronic, Inc. (NYSE:MDT) announced today that it has received 510(k) 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.

“We are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products”

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."

"We are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products," said Mark Fletcher, President of the Surgical Technologies business at Medtronic, Inc. "The SBS 5.0 utilizes the effectiveness of our patented Transcollation technology in preventing and stopping bleeding during surgery, and it will deliver considerable value to surgeons, patients, and hospitals alike."