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FDA Clears Kinetic Concepts VAC Therapy System

Kinetic Concepts (KCI) has received FDA 510(k) clearance to market its proprietary Vacuum Assisted Closure (VAC) Therapy System, for the treatment of venous insufficiency ulcers, also known as venous leg ulcers (VLUs).

VLUs are often hard-to-heal, recalcitrant wounds that pose clinical challenges. They can be painful and debilitating, seriously impacting a patient’s physical and emotional quality of life.

Reportedly, VLUs affect an estimated 500,000 Americans at an annual cost of more than $1bn. KCI estimates its total market opportunity in the US for the treatment of these wounds at more than $300m.

Mike Genau, president of KCI’s Active Healing Solutions business unit, said: “KCI’s business is about helping people heal and restoring them to active, healthy lives. We are able to use our VAC Therapy System to treat all three major categories of chronic wounds: diabetic foot ulcers, pressure ulcers and venous leg ulcers. This extends KCI’s reach across the entire chronic wound care market.”

John Lantis, chief of Vascular and Endovascular Surgery at St Luke’s Roosevelt Hospital Center and associate clinical professor of Surgery, Columbia University, New York, said: “In our practice, the VAC Therapy System has proven very effective in treating complex venous leg ulcers.

“The benefits VAC Therapy delivers, especially in the treatment of massive ulcers and those with difficult-to-manage drainage, are significant. In addition, a clinical study has shown that the time to wound bed preparation is noticeably reduced when compared to traditional therapies.”