KCI Announces FDA Clearance of ABThera[TM] Open Abdomen Dressing.
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KCI Kodak Canada Inc. ) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) to market its ABThera[TM] Open Abdomen Dressing. Earlier this year, the FDA cleared the ABThera[TM] Open Abdomen Negative Pressure Therapy Unit. Together, the ABThera[TM] 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 viscera /vis·ce·ra/ (vis´er-ah) plural of viscus.
1. The soft internal organs of the body, especially those contained within the abdominal and thoracic cavities. , including but not limited to abdominal compartment syndrome Compartment syndrome
Compartment syndrome is a condition in which a muscle swells but is constricted by the connective tissue around it, which cuts off blood supply to the muscle. .
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 edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts. , thus assisting in primary fascial fascial,
adj relating to the fascial. closure of abdominal wall. The ABThera[TM] 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "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[TM] Open Abdomen Negative Pressure Therapy System this summer."
Kinetic Concepts, Inc. is a leading global medical technology company devoted to the discovery, development, manufacture and marketing of innovative, high-technology therapies and products for the wound care, tissue regeneration and therapeutic support system markets. Headquartered in San Antonio, Texas “San Antonio” redirects here. For other uses, see San Antonio (disambiguation).
San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S. , KCI's success spans more than three decades and can be traced to a history deeply rooted in innovation and a passion for significantly improving the healing - and the lives - of patients around the world.
KCI's three primary businesses include:
Advanced Wound Care - Includes KCI's proprietary Vacuum Assisted Closure[R], or V.A.C.[R] Therapy System, which has been clinically demonstrated to promote wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by through unique mechanisms of action while reducing the overall cost of treating patients with complex wounds.
Regenerative Medicine - Represented by KCI's LifeCell business and includes tissue-based products for use in reconstructive, orthopedic and urogynecologic surgical procedures to repair soft tissue defects.
Therapeutic Support Systems - Includes specialty hospital beds, mattress replacement systems and overlays designed to address pulmonary complications associated with immobility, to reduce skin breakdown and assist caregivers in the safe and dignified handling of patients of size.
The company employs 6,700 people and markets its products in more than 20 countries. For more information about KCI, and how its products are changing the practice of medicine, visit www.KCI1.com.
This press release contains forward-looking statements regarding the expected impact of the litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called litigation. ruling and the Company's future plans. Forward-looking statements may contain words such as believes, expects, anticipates, estimates, projects, intends, should, seeks, future, continue, or the negative of such terms, or other comparable terminology. Forward-looking statements are subject to risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from those expressed in or indicated by them. Additional risks and factors are identified in KCI's filings with the U.S. Securities Exchange Commission (the SEC), including its Annual Report on Form 10-K for the fiscal year ending December 31, 2008 which is available on the SEC's Web site at http://www.sec.gov. KCI undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.