Healthcare Industry News:  Ampion 

Devices Ophthalmology FDA

 News Release - May 17, 2007

Ascent Healthcare Receives 510(k) Clearance on Alcon MACKOOL Phaco Tips

PHOENIX--(HSMN NewsFeed)--Ascent Healthcare Solutions announced today that the U.S. Food and Drug Administration (FDA) has cleared Ascent's 510(k) to reprocess the AlconŽ MACKOOL phacoemulsification tips. The cleared 510(k) covers all 15 model numbers within the MACKOOL product series. Ascent is the only reprocessor to receive a 510(k) clearance for these devices. This is Ascent's 78th cleared 510(k), the most FDA clearances held by any medical device reprocessing company.

"With the cost of healthcare supplies rising at an ever increasing rate, using devices reprocessed according to FDA guidelines can safely save hospitals and eye surgery centers thousands of dollars each year and reduce the impact on local landfills. In most cases, reprocessed devices save approximately 40 to 60 percent over original device costs," says John Grotting, Ascent's CEO. "A 200-bed hospital or free-standing outpatient eye center performing 1,000 to 1,500 annual procedures can save approximately $50,000 to $60,000 each year on these devices alone. Our hospital and clinic partners understand that reprocessing savings helps offset costs and can lead to improved patient care by funding clinical salaries and the latest medical technology."

This clearance expands the already extensive roster of reprocessed phaco tips offered by Ascent. The MACKOOL phaco tip series features sheathing over the needle to provide thermal protection. The tips are used during cataract surgery and harness ultrasonic energy to emulsify and excise cataract tissues in ophthalmic microsurgical procedures. Ascent's engineers have validated the MACKOOL devices according to the strict regulatory guidelines enforced by the FDA. Roughly two million cataract surgeries take place annually in the U.S., providing hospitals and outpatient surgery centers an opportunity to redirect the hundreds of thousands in supply savings generated annually through reprocessing to their patient care initiatives.

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 10,000 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. The company has also been recognized as a "ChAmpion for Change" by Hospitals for a Healthy Environment (H2E) in recognition of the dramatic environmental benefits reprocessing by Ascent provides to U.S. hospitals and surgery centers. For more information about Ascent Healthcare Solutions, visit www.ascenths.com.


Source: Ascent Healthcare Solutions

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