Alliance Medical Receives Two Additional 510K Clearances for Electrophysiology Catheters.

PHOENIX -- Alliance Medical Corporation (Alliance), a leading reprocessor of single-use medical devices (SUDs), today announced U.S. Food and Drug Administration (FDA) has cleared the final two 510(k)s filed by the company in response to the agency's Supplemental Validation Submission request. The two clearances cover reprocessed electrophysiology (EP) catheters by Daig and EP Technologies. The FDA's decision to grant Alliance the 510(k) clearance illustrates Alliance's full compliance with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

"Alliance has an excellent working relationship with the FDA and remains committed to working closely with them to ensure that we can continue to provide our customers with the safest, most comprehensive reprocessing program available," said Don Selvey, vice president of Regulatory Affairs for Alliance Medical. "The FDA's clearance of these two 510(k)s is further proof of the agency's confirmation that reprocessed devices are at least as safe as other medical devices."

"With these two clearances for EP catheters and the others we have received during the last few months, Alliance can now reprocess more devices than even before the SVS deadline," stated Rick Ferreira, president of Alliance Medical. "Our customers continue to request our help with controlling their spiraling supply costs. We will continue to seek solutions for them by adding to our service offerings."

The newly cleared reprocessed devices are specially designed electrode catheters that transmit electrical impulses. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Once reprocessed, these catheters are intended to be used for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Having safely reprocessed more than 12 million SUDs, Alliance is one of the industry's most trusted device reprocessing companies, providing hands-on support for customers. Alliance employs clinically trained and experienced service technicians and account executives who utilize its clinically focused, three-phased client support program, Assessment, Implementation and Management (AIM), to set up and manage the most efficient and effective SUD reprocessing program. The savings health care facilities achieve as a result can be used for vital patient services, new medical technology and nursing salaries, all of which lead to improved patient care.

About Alliance Medical

Alliance Medical Corporation is a leading reprocessor of specific single-use medical devices (SUDs) and has safely reprocessed more than 12 million SUDs, saving hospitals and surgery centers in excess of $150 million. Alliance goes beyond providing technically superior medical device reprocessing services to deliver guaranteed maximum supply-cost savings to leading health care organizations. Alliance is differentiated by our unwavering partnership commitment, clinical implementation expertise and dedicated field associates, which together ensure that we exceed our partners' goals and expectations. The Company's services focus on reducing supply costs of hospitals and surgery centers suffering from shrinking reimbursements and increasing costs. Alliance has agreements with leading national group purchasing organizations, alliances and supply chain service firms, including VHA, HealthTrust Purchasing Group (HPG), Broadlane and University HealthSystem Consortium (UHC), as well as a number of nationally recognized hospital integrated delivery networks, including Banner Health and Henry Ford Health System that collectively represent more than 4,000 healthcare facilities. For more information about Alliance Medical Corporation, visit www.alliance-medical.com; or call 888.888.3433.