FDA Clears Medtronic Bipolar Sealer

Minneapolis, Minn.-based Medtronic Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Aquamantys 3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopedic portfolio of the company’s advanced energy business.

The new Aquamantys device combines hemostatic 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 Medtronic claims reduces blood loss and maintains patient hemoglobin levels when used during orthopedic procedures. Medtronic acquired much of its transcollation technology though the purchase of Portsmouth, N.H.-based Salient Surgical Technologies in July last year. Transcollation is used in place of conventional electrocauterization. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased hospital length of stay.

Roger Emerson, M.D., a surgeon at Presbyterian Hospital, Baylor Regional Medical Center at Plano Joint Replacement Center in Plano, Texas, noted that combining cutting and transcollation into a single device has the potential to simplify workflow by reducing the number of tool changes and therefore may result in a time savings for the surgeon.

Medtronic provides medical technology in six sectors: cardiac rhythm disease management, spinal and biologics, cardiovascular, neuromodulation, diabetes, and surgical technologies