Healthcare Industry News:  Ascent Healthcare 

Devices FDA

 News Release - December 20, 2006

Ascent Healthcare Receives 510(k) Clearance on Carter-Thomason CloseSure(R) System

PHOENIX--(HSMN NewsFeed)--Ascent Healthcare Solutions (formerly Alliance Medical Corp. and Vanguard Medical Concepts) announced today that the U.S. Food and Drug Administration (FDA) has cleared Ascent's 510(k) to reprocess the Inlet Carter-Thomason CloseSure® System model #CTI-512N. The cleared 510(k) covers all three components of the system: a 5 mm and a 10/12 mm Pilot® suture passer guide and the Carter-Thomason® suture passer. Ascent is the only reprocessor to receive a 510(k) clearance for this system.

The system, which offers an alternative to hand suturing, is designed to ensure complete trocar wound closure after laparoscopic surgery and to prevent post-surgical herniation in obese patients, a common problem. Complications caused by hand suturing can increase risk to patients by prolonging procedures and time spent under anesthesia. The Inlet Carter-Thomason CloseSure System is the only device that provides full-thickness suturing of all port sites.

Using Carter-Thomason CloseSure Systems reprocessed by Ascent will save a mid-sized hospital (about 250 beds) approximately $18,000 a year - about $50 per device. Additionally, each hospital that uses these devices will eliminate approximately 100 pounds of medical waste annually.

"Our hospital partners have reported difficulty in obtaining sufficient quantities of this popular device," stated Rick Ferreira, Ascent's chief operating officer. "They are eager to add the devices reprocessed by Ascent to their inventory, especially at a savings of about 45 percent."

Carter-Thomason CloseSure Systems reprocessed by Ascent are rinsed, soaked, brushed and sonicated in disinfectant to remove contaminants located on the outside of the device. The devices are then attached to a specially designed manifold that flushes the inner lumens with cleaning solution. As part of functional testing, each suture passer undergoes an actuation test to ensure the device tip opens and closes smoothly. All devices are sterilized using 100 percent ethylene oxide to an assurance level of 10(-6). Residuals do not exceed recommended limits of ISO 10993-7.

"When an innovative medical device enters the market, the cost can sometimes slow adoption," explained Ferreira. "Ascent's engineering staff performs comprehensive evaluations on new devices to identify those that can be safely reprocessed. We are pleased that reprocessing these devices offers hospitals a cost-effective means of improving patient care."

Ascent Healthcare Solutions and its predecessor companies have safely reprocessed more than 50 million single-use devices for over 1,700 healthcare facilities nationwide, including most of the U.S. News and World Report "Honor Roll" hospitals. In 2006, the company will save hospitals more than $90 million in supply expenses and eliminate more than 7,000 tons from U.S. landfills.

About Ascent Healthcare Solutions

Ascent Healthcare Solutions, the leading independent third-party reprocessor of single-use medical devices (SUDs), has reprocessed more than 50 million SUDs for over 1,700 healthcare facilities nationwide. 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.ascenths.com.

Carter-Thomason is a registered trademark of Inlet Medical Inc.


Source: Ascent Healthcare Solutions

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