KCI Announces FDA Clearance Of ABThera™ Open Abdomen Dressing

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals;  Dermatology
Article Date: 22 May 2009 - 4:00 PDT

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Kinetic Concepts, Inc. (NYSE: KCI) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ABThera™ Open Abdomen Dressing. Earlier this year, the FDA cleared the ABThera™ Open Abdomen Negative Pressure Therapy Unit. Together, the ABThera™ Open Abdomen Negative Pressure Therapy System will be indicated for temporary bridging of abdominal wall openings where primary closure is not possible or repeat abdominal entries are necessary. The intended use of the system is for open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome.

This unique, proprietary system is designed to improve therapy in the management of the complex open abdomen by actively removing fluids and infectious material, and by reducing interstitial edema, thus assisting in primary fascial closure of abdominal wall. The ABThera™ Open Abdomen Negative Pressure Therapy System expands the offerings of KCI's negative pressure technology platform into the surgical and trauma operating theaters.

"We are pleased to receive clearance for this important therapy," said Catherine M. Burzik, KCI's President and CEO. "At KCI, we continue to leverage our strengths and core technology competencies to provide high impact therapies and address clinical unmet needs. Expansion and growth in the surgical arena is a strategic goal for the company and we look forward to launching the ABThera™ Open Abdomen Negative Pressure Therapy System this summer."

Source
Kinetic Concepts, Inc