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Medical Devices / Regulatory Affairs / Submissions and Approvals

Kinetic Concepts’ V.A.C. Via Wins FDA 510(k) Nod

Nov. 26, 2013
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The FDA has granted 510(k) clearance for Kinetic Concepts’ V.A.C. Via negative-pressure wound therapy device for patients whose wounds drain 80 mL or less of exudate per day.

In developing the V.A.C. Via Therapy System, KCI used an internal reporting system to gather customer feedback on the company’s previous-generation system. The single-patient portable device provides simplified wound care to patients in or transitioning out of the hospital, providing convenience for the patient and cutting costs of extended hospital stays, the company says.

The treatment involves tearing the V.A.C. Via Spiral GranuFoam so that foam can be placed in the wound. The foam is spread evenly and covered with a drape.

The company expects to have the device on the market by early December. The V.A.C. Via is already approved in Canada, the EU and Australia, and KCI is looking into approvals in other global markets. — Lena Freund

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