FDA clears Medtronic’s bipolar sealer with cutting for orthopaedic surgery

96

The US Food and Drug Administration (FDA) has given 510(k) clearance to Medtronic for its Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopaedic portfolio of the company’s Advanced Energy business.

The BSC 9.1S Bipolar Sealer with Cutting gives surgeons the ability to optimise efficiency in surgical cases by combining haemostatic sealing capabilities for soft tissue and bone and monopolar cutting functionality in a single device. The device uses Transcollation technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and maintain patient haemoglobin levels when used during orthopaedic procedures.

Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased hospital length of stay.

“The BSC 9.1S combining cutting and Transcollation into a single device could simplify workflow by reducing the number of tool changes and therefore may result in a time savings for the surgeon,” said Roger Emerson, a surgeon at Presbyterian Hospital, Baylor Regional Medical Center at Plano Joint Replacement Center.