Endourologists Now Have a New Category of Device For Stone Extraction to Help Render Patients Free from Kidney Stones and Stones in the Urinary Tract

Business Wire, April 29, 2008

NGage[TM] Nitinol Stone Extractor from Cook Medical Combines Stone Graspers and Baskets Enables Greater Function and Control During Stone Retrieval Procedures

BLOOMINGTON, Ind. -- The NGage Nitinol Stone Extractor, engineered and manufactured by Cook Medical , represents an entirely new category in the evolution of stone extraction. Utilizing Cook's revolutionary nitinol technology, the NGage allows physicians to easily engage, release and extract stones even in the most difficult anatomy while providing improved irrigation, visibility and enhanced efficiency.

Traditional stone retrieval devices are often not able to grasp or release stone fragments located within the kidney or ureter, which can lead to increased patient discomfort and the need for additional extraction procedures. In recent clinical evaluations, the breakthrough NGage proved more effective than standard devices in grasping and holding fragments in the kidney and ureter. Its retention strength was also demonstrated to be 1.5 times stronger than traditional graspers. These studies, conducted at the University of Texas Southwestern Medical Center in Dallas and Oregon Health and Science University in Portland, were presented at the 2007 World Congress of Endourology in Cancun, Mexico in November 2007.

The NGage is uniquely engineered from nitinol, a shape-memory alloy that combines nickel and titanium. As a result, the extractor retains its shape following extreme torsion, yet is flexible enough for a physician to guide during stone manipulation without damage to surrounding renal tissue. The duality of the NGage is designed to secure and grip kidney or ureteral stones firmly and also extract and release stones easily, enabling urologists greater control during stone retrieval procedures. Available in a variety of sizes, diameters of 1.7 French and 2.2 French, the NGage can meet various procedural needs with increased flow, enhanced visibility and improved deflection allowing physicians to entrap stone fragments as small as 1 millimeter.

Additional research studies conducted at the University of Texas Southwestern (UTSW) in Dallas and also presented at the 2007 World Congress of Endourology showed the NGage captures and retains stones similar to a stone basket while having the releasing capabilities of a stone retrieval grasper.

Dr. Margaret Pearle, professor of urology and internal medicine at the University of Texas Southwestern Medical Center in Dallas describes the capabilities of the NGage, "Our studies at UTSW show that NGage has 50 percent greater retention strength than traditional graspers. The device also has demonstrated a superior ability to release simulated stone fragments when compared to both standard and multi-wire nitinol stone extraction baskets."

Each year, more than 1 million kidney stone cases are diagnosed in the U.S., with an estimated 10 percent of Americans destined to suffer at some point in their lives. According to the American Urological Association, the number of people in the United States with kidney stones has been increasing over the past 20 years. Kidney stones typically strike people between the ages of 20 and 40. Additionally, when an individual forms a stone, there is a 50 percent chance he or she will develop another stone. Although there are many treatments and surgical options for kidney stones, devices have been limited in their ability to capture small stone fragments which frequently result in secondary procedures.

"The NGage has demonstrated a superior ability to securely capture and release kidney stones throughout the urinary tract, even in the most challenging locations," said Jerry French, senior vice president and global strategic business unit leader for Cook Medical's Urology division. "We are pleased to now offer this device to physicians, as part of Cook's ongoing efforts to help urologists render their patients stone-free."

About Cook Medical

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.