Bloomington, IN -- Cook Medical has announced a significant milestone for its EVOLUTION® Mechanical Dilator Sheath technology, an innovative new tool designed to remove faulty, ineffective leads in patients with cardiac pacemakers. To date, 200 medical centers in the United States have adopted the breakthrough technology that utilizes venous entry during pacemaker lead extraction procedures. Cook's EVOLUTION has quickly proven to be an attractive alternative to current laser and other powered techniques as it is less invasive, more intuitive to use and approximately half the cost of laser-powered sheaths.

In the U.S., more than 20,000 to 25,000 leads are extracted annually. Prior to EVOLUTION, leads were removed either through laser extraction systems, manual dilator sheaths or with a 'snare' under local or general anesthetic. These extraction methods had disadvantages in terms of cost, time and or potential patient adverse events. Designed with simplicity, effectiveness and ease-of-use in mind, EVOLUTION addresses the need for a viable alternative to laser powered extraction. The device is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects and actually minimizes the risk of vascular perforations seen with laser powered sheaths utilizing a forward depth of cut.

"In less than one year, EVOLUTION has been embraced by some of the top medical facilities and surgeons in the country" said Lou Goode, president of Cook Vascular, manufacturer of the EVOLUTION device. "We believe that our advanced mechanical alternative ultimately decreases the amount of trauma caused to the patient, thereby reducing the potential risk of adverse events during the procedure. That is an important consideration for the 200 centers that have adopted Evolution's controlled mechanical powered technique."
As one of the only private companies in the cardiac medical device industry, Cook has the unique ability to remain agile in the research and development of new and advanced medical devices. As such, the company has achieved strong momentum in the space, most recently with the launch of EVOLUTION Shortie at Heart Rhythm 2008. The Shortie is a natural adjunct to EVOLUTION that employs a shorter length to enhance physician control and a specialized distal tip that enables physicians to succinctly negotiate through tough fibrous binding adhesions.

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