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Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery


Published on 2012-01-23 06:07:36 - Market Wire
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MINNEAPOLIS--([ ])--Medtronic, Inc. (NYSE:MDT) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the companyas Advanced Energy business.

"We are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products"

The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time.

aThe SBS 5.0 is a great combination tool that will allow surgeons to treat cut muscle planes as well as compress and treat epidural veins with a single device,a said Dr. Paul Santiago, a surgeon at Washington University School of Medicine.aThis will be particularly useful in cases like 1-2 level TLIFs/PLIFs in which you want the ability to address both of these needs but the economics can make using multiple devices difficult.a

aWe are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products,a said Mark Fletcher, President of the Surgical Technologies business at Medtronic, Inc. aThe SBS 5.0 utilizes the effectiveness of our patented Transcollation technology in preventing and stopping bleeding during surgery, and it will deliver considerable value to surgeons, patients, and hospitals alike.a

About Medtronic

Medtronic, Inc. ([ www.medtronic.com ]), headquartered in Minneapolis, is the global leader in medical technology a" alleviating pain, restoring health and extending life for millions of people around the world.

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.