Healthcare Industry News: V.A.C.%20Therapy
News Release - June 11, 2007
KCI Announces U.S. Food and Drug Administration Clearance for Next-Generation V.A.C.(R) Therapy Technologies Across Multiple Care Settings Including Home UseSAN 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 new claims across all care settings for two of KCI's next-generation V.A.C.® Therapy Systems: the InfoV.A.C.(TM) Therapy System and the ActiV.A.C.(TM) Therapy System. The FDA clearances include new claims that were granted after review of extensive clinical evidence provided by KCI and further differentiate V.A.C. Therapy in the marketplace as the only negative pressure wound therapy (NPWT) systems specifically cleared by the FDA for all care settings, including home use. These next generation technologies give physicians, care providers and patients new features and benefits to ensure optimal delivery of safe and effective NPWT. KCI intends to broadly launch these new V.A.C. Therapy Systems starting this summer in both domestic and international markets.
"The launch of these new products demonstrates KCI's commitment to its customers by bringing innovative, leading-edge technology to the field of advanced wound care," said Catherine M. Burzik, President and Chief Executive Officer of KCI. "These new systems continue to differentiate KCI's proven V.A.C. Therapy technology by combining innovative technologies with ease-of-use features to create the most effective suite of products for the treatment of serious, complex wounds."
While InfoV.A.C. is primarily intended for use in the acute care setting and ActiV.A.C. is primarily intended for the homecare setting, both systems share several new features and patent-pending technologies including a common, intuitive touch screen navigation system that makes the products easier to use and better facilitates transitions across care settings.
"These next-generation V.A.C. Therapy technologies combine intuitive, easy-to-use operating features with technological advancements such as SensaT.R.A.C.(TM) and Seal Check(TM) that simplify the application, monitoring and documentation of the wound healing process," said Todd Fruchterman, M.D., PhD, KCI's Chief Technology Officer. "By improving patient compliance and ensuring optimal delivery of NPWT, these new therapy systems will improve upon the already outstanding outcomes for which V.A.C. Therapy is recognized. The FDA clearance of our new V.A.C. Therapy Systems for use in all care settings, including the home, is a very significant development in the evolution of NPWT."
About The New V.A.C. Therapy Systems
The InfoV.A.C. Therapy System is over 50% lighter and smaller than its predecessor system and provides a new digital wound imaging feature that allows caregivers to monitor and document wound healing progress. Digital images can be reviewed on-screen or transferred electronically to help document patient progress, allowing for the convenient sharing of wound information among caregivers and payers who require evidence of wound healing.
The new ActiV.A.C. Therapy System will be used predominantly in the homecare setting and addresses demand for a simpler, lighter, and lower profile design that will enhance patient comfort and mobility. The ActiV.A.C. Therapy System features newly developed technology that automatically documents the patient's therapy history and treatment times. Reports are electronically stored in the system and can be reviewed on-screen or downloaded to a computer.
Common to both therapy systems are new technologies that simplify the administration of V.A.C. Therapy. The new SensaT.R.A.C. Technology allows caregivers and patients to more effectively monitor and maintain target pressure at the wound site. The Seal Check feature helps caregivers and patients identify and resolve potential dressing leaks through the use of both visible and audible cues. A new, intuitive touch screen makes the products easier to use.
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 and can help reduce the overall cost of patient care. Our advanced wound-care systems incorporate our proprietary V.A.C. Therapy technology, which has been demonstrated clinically to help promote wound healing through unique mechanisms of action 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, to prevent skin breakdown and assist caregivers in the safe and dignified handling of obese patients. 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 organizations and patients' homes, both in the United States and abroad.
This press release contains forward-looking statements. These forward-looking statements are based on our current expectations and are subject to a number of risks and uncertainties. All information set forth in this release is as of its date, and 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, 2006 and our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2007, on file with the SEC and available at the SEC's website at www.sec.gov.
Source: Kinetic Concepts
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