Cook Medical Launches An EVOLUTION(R) For Lead Extraction

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 30 Nov 2007 - 2:00 PDT

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Cook Medical launches the EVOLUTION(R) Mechanical Dilator Sheath Set from its Coronary strategic business unit. The first showcase for this innovation in lead extraction will be at the XIII World Congress on Cardiac Pacing and Electrophysiology in Rome between 2nd and 6th December.

By the end of 2007 approximately 750,000 leads will have been implanted in patients with pacemakers and defibrillators across Europe. Between 4 and 7 per cent of these leads will need to be extracted at some point due to damage, infection or the inability to implant new leads due to the presence of existing ones. 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.

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 maximising 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.

Barry Norlander, Global Marketing Manager for Cook Vascular Incorporated, says: "Increasing numbers of pacemakers, defibrillators and leads are placed in patients every year in Europe. With this rise in placements comes an associated increase in requirement for cardiac lead extraction, a complex and challenging process for doctors to perform.

"We've designed EVOLUTION to be an extremely attractive alternative to current lead extraction technology. 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. The novel mechanical tip design of the EVOLUTION does not ablate tissue ahead of its distal tip. By not having an energized "forward depth of cut", the tip may progress through binding scar tissue without inadvertently desiccating tissue that may be unintentionally contacted.

"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 organisations. We're excited to see the benefits that EVOLUTION will bring to health providers, doctors and patients in the UK."

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 Magazine.

http://www.cookmedical.com

About the XIII World Congress on Cardiac Pacing and Electrophysiology
December 2nd - 6th, Rome Marriott Park Hotel

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 Electrophysioloy is to be very educative, underlining the evidence-based clinical practice in the field of arrhythmology for clinical cardiologists and young electrophysiologists.

For more information, visit this link.

Cook Medical

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