FDA clears Medtronic Aquamantys system for hemostatic sealing
Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for its Aquamantys3 System as well as the new 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand pieces.
Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for its Aquamantys3 System as well as the new 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand pieces.
The Aquamantys system offers surgeons and operating room staff enhanced features to improve ease of use, including a graphic user interface and an integrated cassette for simplified setup.
The new and existing hand pieces work on the company’s patented transcollation technology and radio frequency (RF) cutting functions, designed to provide hemostatic sealing of soft tissue and bone during surgery.
The addition of the 8.2L Bipolar Sealer with Cutting can potentially reduce device exchanges during surgery.
Medtronic Surgical Technologies division president Mark Fletcher said the Aquamantys System has been a valuable addition in the operating room, giving doctors the ability to better control intra-operative bleeding through transcollation technology.
"The new Aquamantys3 platform and the addition of 8.2L makes us even more valuable, and we look forward to the additional opportunities we can offer surgeons on this new product platform," Fletcher said.