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.

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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.

Free Report

Find the right pricing strategy for your medical device

A proprietary algorithm that leverages numerous pricing sources, with an emphasis on real-world data
Estimates of the likely spread of selling prices per brand and manufacturer, as well as 3-year forecasts for prices
Medical device pricing data that can be tracked by market, company, and brand
Additional categories that can be built on a custom basis

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