Ascent Healthcare Receives 510(k) Clearance to Reprocess Siemens ACUSON AcuNav(TM) Ultrasound Catheter up to Four Times.PHOENIX -- First graph, second sentence should read: Validation data submitted to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. covered all available models (sted Covered devices include the 10 French and 8 French models). The corrected release reads: ASCENT HEALTHCARE RECEIVES 510(K) CLEARANCE TO REPROCESS re·proc·ess tr.v. re·proc·essed, re·proc·ess·ing, re·proc·ess·es To cause to undergo special or additional processing before reuse. Verb 1. SIEMENS ACUSON ACUNAV(TM) ULTRASOUND CATHETER UP TO FOUR TIMES Ascent Healthcare Solutions announced today that the U.S. Food and Drug Administration (FDA) has increased the number of times that Ascent can reprocess the AcuNav[TM] Ultrasound Catheter from two to up to four times. Validation data submitted to the FDA covered all available models. The catheters provide electrophysiologists and interventional cardiologists with high- quality images and blood flow information throughout the entire heart for the diagnosis of certain cardiac arrhythmias. Ascent originally received clearance to reprocess the catheters in March 2005. This expanded FDA clearance to reprocess the AcuNav Ultrasound Catheter up to four times reflects Ascent's proven ability to clean, sterilize sterilize /ster·i·lize/ (ster´i-liz) 1. to render sterile; to free from microorganisms. 2. to render incapable of reproduction. ster·il·ize v. 1. and ensure device functionality. As a part of Ascent's validation procedures required for FDA 510(k) clearance, numerous, repeatable mechanical and electrical tests are performed. Ascent seeks to provide the broadest array of cost-effective reprocessed devices. "Cath labs that reprocess the catheter four times, rather than buying original product will reduce their cost per procedure by an average of $1,000. That is a valuable investment that goes straight to their bottom line," says Rick Ferreira, chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. for Ascent. "At the same time, those hospitals contribute to a 'greener' world by eliminating the need to needlessly dispose of devices." Ascent's reprocessed AcuNav Ultrasound diagnostic catheter testing roadmap guarantees 100 percent electrical transducer transducer, device that accepts an input of energy in one form and produces an output of energy in some other form, with a known, fixed relationship between the input and output. functionality for all reprocessed devices through four reprocessing Reprocessing may refer to:
In addition to testing for functionality, Ascent engineers and independent national laboratories performed extensive testing to validate that these reprocessed catheters will be clean, sterile and pyrogen pyrogen /py·ro·gen/ (pi´ro-jen) a fever-producing substance. py·ro·gen n. A substance that produces a fever. free when they are returned to hospitals. About Ascent Healthcare Solutions Since its inception, Ascent Healthcare Solutions, the leading independent third-party reprocessor of single-use medical devices (SUDs), has reprocessed more than 50 million SUDs, saving its customers in excess of $500 million in supply expenses and eliminating over 100,000 tons from local landfills. Ascent's 1,700 hospital partners include most of the U.S. News and World Report "Honor Roll honor roll n. A list of names of people worthy of honor, especially: a. A list of students who have earned high grades during a specified period. b. A list of people who have served in the armed forces. " hospitals. The company has agreements with all leading national group purchasing organizations A group purchasing organization is an entity that leverages the purchasing power of a group of businesses to obtain discounts from vendors based on the collective buying power of the GPO members. Many GPOs are funded by administrative fees that are actually paid by the vendors. as well as numerous nationally recognized hospital integrated delivery networks. For more information about Ascent Healthcare Solutions, visit www.ascenths.com. |
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