Cook Medical launches the EVOLUTION(R) Mechanical Dilator Sheath Set from its Coronary strategic business unit. The first showcase for that innovation in lead extraction will be at the XIII World Congress on Cardiac Pacing and Electrophysiology in Rome amidst 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. amoung 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, moment 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 additionally 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. that 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 supply counter-traction. The aftereffect is that fewer devices of varying size are used, thus saving funds and procedural duration. A without 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 that 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 appealing alternative to current lead extraction technology. Current laser extraction requires a stand alone unit that weighs by 275Kg to capability 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 needed, 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 supply safe, timely and effective treatment for the patient, and easy-to-use devices for physicians. It plus 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.”

Original post by Mallows