KCI receives 510(k) clearance to market V.A.C. Therapy System for treatment of VLUs

Kinetic Concepts, Inc. (NYSE:KCI) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market its proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy System, for the treatment of venous insufficiency ulcers, also known as venous leg ulcers (VLUs).

“In our practice, the V.A.C.® Therapy System has proven very effective in treating complex venous leg ulcers”

"KCI's business is about helping people heal and restoring them to active, healthy lives," according to Mike Genau, president of KCI's Active Healing Solutions™ business unit. "We are now able to use our V.A.C.® 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."

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

"In our practice, the V.A.C.® Therapy System has proven very effective in treating complex venous leg ulcers," said Dr. 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. "The benefits V.A.C.® 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."

VLUs affect an estimated 500,000 Americans at an annual cost of more than $1 billion. KCI estimates its total market opportunity in the U.S. for the treatment of these wounds at more than $300 million.