MINNEAPOLIS–(BUSINESS
WIRE)–Medtronic, Inc. 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
companys Advanced Energy business.
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.
“The 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,” said Dr. Paul Santiago, a surgeon at Washington
University School of Medicine. “This 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.”
“We are excited to offer surgeons this new addition to our
ever-growing spine portfolio of advanced energy products,” said Mark Fletcher,
President of the Surgical Technologies business at Medtronic, Inc. “The 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.”
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical
technology – alleviating pain, restoring health and extending life for millions
of people around the world.
Posted by Sean Fenske, Editor-in-Chief, MDT