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 News Release - November 30, 2007

Cook Medical Launches EVOLUTION(R) for Lead Extraction

Innovation in lead extraction unveiled at the XIII World Congress for Cardiac Pacing in Rome on December 2nd

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical today launched the EVOLUTION® Mechanical Dilator Sheath Set. The first showcase for this innovation in lead extraction will be at the XIII World Congress on Cardiac Pacing and Electrophysiology in Rome, Italy on December 2nd and 6th.

By the end of 2007, approximately 750,000 leads will have been implanted in patients with pacemakers and defibrillators across Europe. In Europe, 30,000 to 52,000 of these leads will need to be extracted as a result of damage, infection or the inability to implant new leads due to the presence of existing ones. In the U.S., more than 20,000 to 25,000 leads are extracted annually. Currently, leads can be removed either using laser extraction systems or with a ‘snare’ under local or general anaesthetic, both extraction methods may have disadvantages in terms of cost, time and or potential patient adverse events.

Designed with simplicity, effectiveness and ease-of-use in mind, EVOLUTION is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. It requires less surgical finesse and is more intuitive to use than laser powered systems. It is also designed to negotiate chronic heavily fibrosed and calcified lesions more rapidly and effectively than powered sheaths utilizing forward depth of tissue disruption.

“We’ve designed EVOLUTION to be an extremely attractive alternative to current lead extraction technology,” said Barry Norlander, global marketing manager for Cook Vascular Incorporated. “Current laser extraction requires a stand alone unit that weighs over 275Kg to power the device. Additionally, laser sheaths need calibrating before each operation. EVOLUTION needs no additional capital equipment nor annual maintenance contracts and inspections. No electricity is required, neither is an on-site laser technician – it’s a viable alternative, both from an operation and fiscal efficiency perspective. With EVOLUTION we hope to minimize the risk of vascular perforations seen with laser powered extraction.”

How does it work?

Coming in a variety of sizes, from 7.0 to 13 French, EVOLUTION comprises a threaded barrel distal tip design. It consists of a flexible rotating sheath that succinctly separates fibrous binding sites from the leads that need extracting. This inner, exotic braided polymer sheath, shielded by an outer telescoping polymer sheath, connects to a handle, or trigger, which rotates it mechanically. Its mechanical trigger allows the user to better feel progress along the lead and through lesions, thereby maximizing physician control.

The metal distal tip can be used to provide counter-traction. The result is that fewer devices of varying size are used, thus saving funds and procedural time. A single sheath set can be used to extract multiple leads of the same diameter from one patient.

“With the launch of EVOLUTION, we’re continuing the Cook tradition of delivering the best, most versatile devices that provide safe, timely and effective treatment for the patient, and easy-to-use devices for physicians. It also reduces the financial burden on health organizations. We’re excited to see the benefits that EVOLUTION will bring to health providers, doctors and patients in the U.S. market.”

About Cook Medical

Cook Medical was the first company to introduce interventional devices in the United States. Today, the company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotechnology to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year for 2006 from Medical Device and Diagnostic Industry Magazine. For more information, visit: www.Cookmedical.com

About the XIII World Congress on Cardiac Pacing and Electrophysiology

December 2nd – 6th, Rome Marriott Park Hotel, Rome, Italy

The XIII World Congress on Cardiac Pacing and Electrophysiology will be held on December 2 - 6, 2007 in Rome. The Board members of the International Cardiac Pacing and Electrophysiology Society (ICPES) assigned to me the task to coordinate both the scientific and logistic organization.

The ICPES World Congress is held every four years since more than three decades and it has always been very successful. The attendance in the last two editions (Berlin, Hong Kong) was very high, including more than 5.000 electrophysiologists and clinical cardiologists from all over the world.

The mission of the World Congress of Cardiac Pacing and Electrophysiology is to be very educative, underlining the evidence-based clinical practice in the field of arrhythmology for clinical cardiologists and young electrophysiologists.


Source: Cook Medical

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