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Home » Medtronic wins 510(k) for latest surgical sealer

Medtronic wins 510(k) for latest surgical sealer

July 30, 2012 By MassDevice staff

Medtronic logo

Medtronic (NYSE:MDT) today announced 510(k) clearance of the latest device in its line of Aquamantys orthopedic surgical sealers, the Aquamantys 3 BSC 9.1S bipolar sealer with cutting.

The new Aquamantys 3 device, adding to Medtronic’s advanced energy portfolio, combines the ability to seal soft tissue and bone and provides cutting capabilities in a single tool.

The Minneapolis-based medical device giant acquired the Aquamantys technology through the $105 million acquisition of Salient, which closed last year.

The Aquamantys system uses proprietary transcollation technology, using radiofrequency energy and saline to hemostatically seal soft tissue and bone during surgery. The technology helps surgeons significantly limit blood loss and reduce the need for blood transfusions.

The BSX 9.1S may also help reduce the number of tool changes a surgeon requires during a procedure, thereby simplifying the operating room workflow, according to a press release.

Earlier this year Medtronic won 510(k) clearance for the Aquamantys SBS 5.0 sheathed bipolar sealer for use both with cut muscle tissue and with epidural veins.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well, Surgical

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