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FDA clears Medtronic new Aquamantys bipolar sealer

The US Food and Drug Administration (FDA) has granted 510(k) approval to Medtronic's Aquamantys3 BSC 9.1S bipolar sealer with cutting, designed for use in orthopaedic surgery.

By utilizing Transcollation technology, the BSC 9.1S Bipolar Sealer with Cutting combines hemostatic sealing capabilities for soft tissue and bone and monopolar cutting functionality in a single device.

Transcollation technology, which is a combination of radiofrequency energy and saline, has shown to reduce blood loss and maintain patient hemoglobin levels when used during orthopaedic procedures.

Baylor Regional Medical Center and Presbyterian Hospital surgeon Roger Emerson said, "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."

Medtronic surgical technologies business president Mark Fletcher said the BSC 9.1S utilizes the effectiveness of the company’s 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," Fletcher added.