Apr 27 2010
Kinetic Concepts, Inc. (NYSE: KCI) issued the following statement today from Catherine Burzik, KCI president and CEO, regarding the U.S. Food and Drug Administration's (FDA) medical device home use initiative:
"KCI applauds the FDA for launching this important initiative to ensure that complex medical devices are used safely in the home by caregivers and patients. We have made it our priority and unwavering responsibility to help caregivers and patients understand how to use our advanced treatments safely. This includes offering a robust education and training program, employing highly trained clinical support staff and providing easy-to-read, patient-specific labeling.
KCI's V.A.C.® Therapy is the only negative pressure wound therapy product to have a FDA home use indication based on substantial clinical and scientific data. The people of KCI have a deep commitment to patient care and safety and support the FDA's goals for this initiative."