Christchurch, New Zealand, August 17, 2007
ARANZ Medical Limited, a leading innovator in wound assessment technology, announces that its Silhouette™ product family has received 510(k) premarket clearance from the US Food and Drug Administration (FDA). Silhouette, an innovative solution for wound imaging, measurement and documentation, is the first device to ever gain such approval from the FDA specifically for this purpose. Gaining FDA clearance allows ARANZ Medical to commence marketing of Silhouette in the US market.
ARANZ Medical Silhouette marks a significant advance in the management of patients with skin wounds. In the US alone, approximately six million people suffer from wounds at any time and with the aging population and increasing prevalence of diabetes this number will rise. As opposed to the largely ad hoc methods that have been used to track wound healing progress to date, Silhouette provides a very efficient, integrated, non-contact, and repeatable solution.
“The Silhouette suite of products is an innovative concept that is improving wound care practice,” says Dr Mark Nixon, Chief Medical Officer at ARANZ Medical Limited. “Over the last 2 years we realized that a better solution could be developed that could be more accurate, more efficient, and more integrated than the current state of the art systems. Working closely with wound care professionals we have developed the Silhouette product suite which has received enthusiastic reviews from wound care professionals on several continents.”
“We have found Silhouette to be efficient, with timely and accurate documentation of the wound dimensions,” reports Dr Michael Moore MD, President and Medical Director of the Wound Institute and Research Centre, Dunmore, Pennsylvania. “In our practice we have found measurements made by SilhouetteMobile to be repeatable, and the portability of the product makes it ideal for use in a wound clinic or home health setting.”
“Receiving FDA clearance for Silhouette is a notable milestone for ARANZ Medical”, reports Bruce Davey, CEO of ARANZ Medical. “With Silhouette’s significant advantages for all participants in the wound care process including patients, nurses, physicians, wound care centers, home health agencies, insurers, reimbursement agencies, and researchers, we believe that Silhouette will find wide appeal with wound care professionals. We are delighted that Silhouette is now available to assist US health care professionals provide superior care for their patients.”
The ARANZ Medical Silhouette is available for sale in the United States.