Healthcare Industry News:  Zimmer 

Devices Orthopaedic FDA

 News Release - November 9, 2006

Ascent Healthcare Receives 510(k) Clearance on Zimmer TransFx External Fixation Devices

PHOENIX--(HSMN NewsFeed)--Ascent Healthcare Solutions (formerly Alliance Medical Corp. and Vanguard Medical Concepts) announced today that the U.S. Food and Drug Administration (FDA) has cleared Ascent's 510(k) to reprocess Zimmer TransFx(TM) External Fixation devices. Ascent has the most extensive list of FDA-cleared reprocessed external fixation devices originally manufactured by industry leaders including Synthes, Smith & Nephew, Stryker Trauma and DePuy Orthopedics (a Johnson & Johnson company).

External fixation devices are used to stabilize selected bone fractures. The modular Zimmer TransFx System provides options in frame construction, simplicity in frame components and ease of transition from one frame size to another. Ascent has clearance to reprocess the intermediate and large rods and clamps that are part of the TransFx system. Ascent will not reprocess the pins that are inserted into bone.

"Hospitals throughout the U.S. are striving to improve patient care and environmental stewardship while seeking prudent solutions to address rising supply costs," stated Rick Ferreira, Ascent's chief operating officer. "Reprocessing with Ascent Healthcare Solutions offers hospitals the opportunity to safely reclaim financial resources that can be invested in staffing, patient care services, medical technology and research, all of which improve patient care. Reprocessing also prevents thousands of tons of devices from being needlessly tossed into landfills every year."

Safety and effectiveness testing during validation included statistically substantiating the mechanical properties of the reprocessed Zimmer TransFx external fixation devices. All devices passed static and dynamic mechanical testing methods, which included cycling devices at a predetermined value and ensuring that no sample failed prior to completion.

Unlike original equipment manufacturers that only test a sample of the devices they manufacture, Ascent's technicians and quality control inspectors examine and test every device at multiple points during reprocessing to ensure they will perform as intended. They reject any device that does not pass every inspection and test.

Ascent Healthcare Solutions and its predecessor companies have safely reprocessed more than 50 million single-use medical devices for over 1,700 healthcare facilities nationwide, including a majority of U.S. News & World Report "Honor Roll" hospitals. In 2006, the company will save hospitals more than $90 million in supply expenses.

About Ascent Healthcare Solutions

Ascent Healthcare Solutions, the leading independent third-party reprocessor of single-use medical devices (SUDs), has reprocessed more than 50 million SUDs for over 1,700 healthcare facilities nationwide. The company's primary reprocessing center and home office are in Phoenix, Ariz. with an additional reprocessing center in Lakeland, Fla. Ascent holds agreements with all leading national group purchasing organizations as well as numerous nationally recognized hospital integrated delivery networks that collectively represent more than 5,000 healthcare facilities. For more information about Ascent Healthcare Solutions, visit www.ascenths.com.


Source: Ascent Healthcare Solutions

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