Healthcare Industry News: ultrasound catheter
News Release - April 24, 2007
Ascent Healthcare Receives 510(k) Clearance to Reprocess Siemens ACUSON AcuNav(TM) Ultrasound Catheter up to Four Times
PHOENIX--(HSMN NewsFeed)--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 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 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 functionality for all reprocessed devices through four reprocessing cycles. Ascent technicians and quality control inspectors examine and test every device at multiple points during reprocessing to ensure that each will perform as intended. They reject any device that does not pass every inspection and test.
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 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" hospitals. The company has agreements with all leading national group purchasing organizations as well as numerous nationally recognized hospital integrated delivery networks. For more information about Ascent Healthcare Solutions, visit www.ascenths.com.
Source: Ascent Healthcare
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