Healthcare Industry News:  reprocessing 

Devices Cardiology FDA

 News Release - September 26, 2006

Ascent Healthcare Receives 510(k) Clearance on Medtronic TORQR CS Series Catheters

PHOENIX--(HSMN NewsFeed)--Ascent Healthcare Solutions (formerly Alliance Medical Corp. and Vanguard Medical Concepts) announced today that the Food and Drug Administration (FDA) has cleared Ascent's 510(k) to reprocess the TORQR CS Series EP catheters manufactured by Medtronic(1).

reprocessing diagnostic EP catheters -- specially designed electrode instruments that transmit electrical impulses -- reduces the cost of an EP study by an average of $300 to $500. A hospital that performs 1,000 or more studies each year could save between $250,000 and $1 million annually. Through rigorous, FDA-approved testing and validations, these devices are assured to be as safe as they were in original condition.

Medtronic Cardio Rhythm Torqr Catheters are fixed curve devices intended for use in diagnostic electrophysiology (EP) procedures. They record intracardiac electrograms and temporary pacing associated with EP studies.

"Through our predecessor companies, Ascent has been a leader in reprocessing a broad array of EP catheters for hospitals around the country," said Don Selvey, vice president of Regulatory Affairs and Quality Assurance for Ascent. "In fact, we are unmatched in our depth of expertise in reprocessing these extremely popular devices. Last year alone, for instance, we reprocessed more than 266,000 EP catheters arising from 462 unique model numbers."

Collectively, Ascent has safely reprocessed more than 50 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. In addition, the company expects to eliminate over 7,000 tons of medical waste from the nation's landfills annually.

(1) TORQR is a registered trademark of Medtronic, Inc.

About Ascent Healthcare Solutions

Ascent Healthcare Solutions, the leading independent third-party reprocessor of specific 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.ascenthealthcaresolutions.com.


Source: Ascent Healthcare Solutions

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