Medtronic receives FDA clearance for new surgical sealer
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Medtronic Inc. announced that it has received FDA 510(k) clearance for the Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting, a new orthopedic surgery instrument that is part of the firm’s Advanced Energy business.
To optimize efficiency during surgery and possibly reduce the need to change tools during procedures, the BSC 9.1S Bipolar Sealer combines hemostatic sealing capabilities for soft tissue and for bone with monopolar cutting functionality, according to a company press release. The device also uses the same Transcollation-brand technology used in other products in Medtronic’s Aquamantys line to reduce patient blood loss and maintain hemoglobin levels during surgery.
“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,” Mark Fletcher, president of the Surgical Technologies business at Medtronic, stated in the release.
“We are excited to offer surgeons this new addition to our ever-growing orthopaedic portfolio of advanced energy products,” Fletcher stated.