Healthcare Industry News:  reprocessing 

Devices FDA

 News Release - April 24, 2006

Ascent Healthcare Solutions Receives FDA Clearance to Increase Cycle Count for Reprocessed EP Catheters

PHOENIX, Ariz.--(HSMN NewsFeed)--April 24, 2006--Ascent Healthcare Solutions (Ascent), the industry's leading reprocessor of single-use medical devices (SUDs), today announced U.S. Food and Drug Administration (FDA) clearance to increase the reprocessing cycle of two different EP catheters, Daig LiveWire and EP Technologies, to six cycle counts. Ascent continues to work to expand its family of FDA-cleared products to provide customers with flexibility in product choices and maximum saving opportunities.

"The FDA's decision to grant Ascent with increased cycle count clearances illustrates the agency's confidence that the reprocessed devices are at least as safe as the originals," said Don Selvey, vice president, Regulatory Affairs and Quality Assurance for Ascent. "By increasing the reprocessing cycle count for one of our most popular products, our valuable customers can further reduce supply chain costs."

With the reprocessing cycle count increased to six for the Diagnostic EP catheters, Ascent's customers will be able to reduce the number of times they are replenishing their supply of original and full cost devices, to further capitalize on their saving potential. Through extensive testing and validations at the high cycle count, these devices meet the highest standard of quality that are as safe as the original devices.

Diagnostic EP catheters, specially designed electrode catheters that transmit electrical impulses, are intended to be used for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Ascent has safely reprocessed more than 40 million SUDs for over 1,700 healthcare facilities nationwide. Ascent expects to help its customers save in excess of $92 million in supply expenses in the coming year, which may be redirected to patient services. Ascent is a major contributor to the healthcare industry's environmental responsibility efforts as an award winning member of Hospitals for a Healthy Environment (H2E). Ascent provides its customers with unparalleled opportunities to promote environmental stewardship and expects to eliminate over 7,000 tons of medical waste from the nation's landfills annually.

About Ascent Healthcare Solutions

Ascent Healthcare Solutions is the leading independent third-party reprocessor of specific single-use medical devices (SUDs) and has reprocessed more than 40 million SUDs for over 1,700 healthcare facilities nationwide. The company's home office is in Phoenix, Ariz. with reprocessing centers in both Phoenix and 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.ascenthealthcaresolutions.com.


Source: Ascent Healthcare Solutions

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