|Medtronic Announces 510(k) Clearance of Bipolar Sealer with Cutting for Orthopaedic Surgery|
MINNEAPOLIS – July 30, 2012 – Medtronic, Inc. (NYSE: MDT) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys®3 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 optimize efficiency in surgical cases by combining 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 has been shown to reduce blood loss and maintain patient hemoglobin 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 Dr. Roger Emerson, a surgeon at Presbyterian Hospital in Plano, Texas.
“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.”
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
-end-Medtronic Media Contacts:
Cindy Resman, Public Relations, 763-505-0291
Jeff Warren, Investor Relations, 763-505-2696