KCI to submit labeling for its products cleared by FDA for home use

Kinetic Concepts, Inc. (NYSE: KCI) today announced it is the first manufacturer to commit to submitting labeling for its products used in the home to the Food and Drug Administration as part of the agency's medical device Home Use Initiative. KCI will voluntarily submit labeling for its products cleared by FDA for home use for inclusion in the home use device labeling repository on the FDA's website.

“We not only commit to take this important and needed step, but believe in the FDA's broad goal of putting patients and safety first. The people of KCI — on behalf of caregivers and patients — look forward to working with the administration to aid this important endeavor.”

As home-based care becomes more prevalent and sophisticated, the FDA is stepping up efforts to ensure complex medical devices have the safeguards needed for safe home use by patients. As part of the initiative, the FDA is launching a 10-month pilot program beginning this summer in which manufacturers of home use devices may voluntarily submit their labeling for posting on a central website repository. The repository will provide a central location for home care patients and caregivers to access important information about the safe use of their devices.

"Patient safety means everything to KCI, and we support the FDA in launching its initiative," said Catherine Burzik, KCI's president and CEO. "We not only commit to take this important and needed step, but believe in the FDA's broad goal of putting patients and safety first. The people of KCI — on behalf of caregivers and patients — look forward to working with the administration to aid this important endeavor."

KCI's ActiV.A.C.^®, InfoV.A.C.^®, V.A.C. Freedom^®, V.A.C. ATS^® and V.A.C.Via™ Therapy Systems were 510(k) cleared with an indication for home use based on substantial clinical and scientific data. Additionally, the company trains almost 50,000 clinicians on V.A.C.^® Therapy usage annually. The company also provides 24/7 phone support line where patients can access staff clinicians.