Healthcare Industry News: V.A.C. Therapy
News Release - October 16, 2006
KCI Announces New FDA Labeling Clearance for V.A.C.(R) Therapy(TM)SAN ANTONIO--(HSMN NewsFeed)--Kinetic Concepts, Inc. (NYSE:KCI ), a global medical technology company with leadership positions in advanced wound care and therapeutic surfaces, today announced that the U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for KCI's V.A.C. negative pressure wound therapy system. Specifically, the FDA has cleared KCI to market and label the unique mechanisms of action of the V.A.C. device, including "preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and removing exudate and infectious material." The expanded Indications for Use are specific to KCI's V.A.C. Therapy devices, which are used to treat a variety of wounds, including chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
"This new clearance is significant because it further substantiates the unique mechanisms of action of V.A.C. Therapy while clearly differentiating V.A.C. Therapy from other offerings in wound care," said Dennert O. Ware, President and Chief Executive Officer of KCI. "V.A.C. Therapy remains the only clinically proven system that delivers effective negative pressure wound therapy to help promote the healing of serious, complex wounds." The growing body of evidence supporting V.A.C. Therapy includes statistically significant results from randomized controlled trials, more than 50 textbook citations, and a large compilation of compelling testimony from clinicians who have treated more than one million patients in the U.S. with V.A.C. Therapy.
The clearance of expanded Indications for Use was issued following the FDA's review of KCI's 510(k) submission on July 31, 2006. KCI submitted a significant amount of clinical evidence demonstrating the mechanisms of action which drive the clinical efficacy of V.A.C. Therapy. The expanded labeling recognizes the clinical benefits of V.A.C. Therapy, which has been demonstrated to deliver positive patient outcomes in all patient care settings across a broad spectrum of wound types.
About V.A.C. Therapy
Our advanced wound care systems incorporate our proprietary Vacuum Assisted ClosureŽ, or V.A.C. technology, which has been clinically demonstrated to help promote wound healing, drive superior clinical outcomes, and provide economic savings for the healthcare system. Today, V.A.C. Therapy is the only negative pressure wound healing technology supported by a robust and growing body of clinical evidence that includes more than: 300 peer-reviewed articles, 350 abstracts, and 50 text-book references. V.A.C.'s proven clinical efficacy is further supported by a unique national service network that offers customers the largest clinical support staff in advanced wound care with 24-hour support and therapy delivery.
Kinetic Concepts, Inc. is a global medical technology company with leadership positions in advanced wound care and therapeutic surfaces. We design, manufacture, market and service a wide range of proprietary products that can improve clinical outcomes while helping to reduce the overall cost of patient care. Our advanced wound care systems incorporate our proprietary V.A.C. technology, which has been clinically demonstrated to help promote wound healing and can help reduce the cost of treating patients with serious wounds. Our therapeutic surfaces, including specialty hospital beds, mattress replacement systems and overlays, are designed to address pulmonary complications associated with immobility and to prevent skin breakdown. We have an infrastructure designed to meet the specific needs of medical professionals and patients across all health care settings including acute care hospitals, extended care facilities and patients' homes both in the United States and abroad.
This press release contains forward-looking statements, which are based on our current expectations and are subject to a number of uncertainties. All information set forth in this release is as of October 16, 2006. We undertake no duty to update this information. More information about the company is described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2006, which are on file with the SEC and available at the SEC's website at www.sec.gov.
Source: Kinetic Concepts
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