510(k) Clearance For Medtronic’s Orthopaedic Bipolar Sealer with Cutting

In short

Medtronic, Inc. has announced the FDA 510(k) clearance for its Aquamantys®3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopaedic portfolio of the company’s Advanced Energy business.


Medtronic says 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. Like other devices in the Aquamantys line, the BSC 9.1S 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.

Clinician comments

“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 Dr. Roger Emerson, a surgeon at Presbyterian Hospital, Baylor Regional Medical Center at Plano Joint Replacement Center.

Company comments

“We are excited to offer surgeons this new addition to our ever-growing orthopaedic portfolio of advanced energy products,” said Mark Fletcher, president of the Surgical Technologies business at Medtronic, Inc. “The BSC 9.1S utilizes the effectiveness of our patented Transcollation technology in preventing and stopping bleeding during surgery and combines it with the added benefit of integral cutting. It will deliver considerable value to surgeons, patients, and hospitals alike.”

Source: Medtronic, Inc.