Healthcare Industry News:  Cook 

Devices Interventional Regulatory

 News Release - October 27, 2008

Cook Medical Receives CE Mark Approval for MiraFlex(TM) High Flow Microcatheter

BJAEVERSKOV, Denmark--(HSMN NewsFeed)--Cook Medical, the world sales leader in the embolisation market, has received CE Mark approval for its MiraFlex™ High Flow Microcatheter. Specially engineered to complement the existing offering of Cook embolisation products and coils, MiraFlex High Flow embodies the latest innovation in microcatheter technology designed to enhance traceability necessary for accessing the most distal vasculature. The catheter is indicated for use in small vessel or superselective anatomy for diagnostic and interventional procedures.

“We are extremely pleased to introduce MiraFlex High Flow to the European market, and look forward to bringing this device to clinicians for use in neurological, peripheral or coronary vasculature practices,” said Rob Lyles, global leader of Cook’s peripheral intervention division. “At Cook, we focus continually on delivering new and innovative products to improve patient outcomes.”

With a generous .025 inch inner diameter, MiraFlex High Flow enables optimal coil delivery and can be used in combination with a wide variety of embolisation materials, including the top-selling MicroNester® and Tornado® Microcoils™ from Cook. A kink-resistant braided construction along the entire length of the catheter shaft to the radiopaque band provides improved torque response and traceability for quicker vessel selection, while maintaining optimal catheter visualisation. The braided design also contributes to the flexibility and durability of the catheter, which carries a rated burst pressure of 1000 psi and achieves the higher flow rates clinicians depend upon.

Each MiraFlex High Flow microcatheter has a hydrophilic coating designed to greatly reduce surface friction, and is engineered with five durometer zones ranging from a stout proximal portion that delivers improved pushability and control, to a soft, flexible distal tip that reduces the risk of vessel trauma.

The standard MiraFlex catheter received U.S. Food and Drug Administration clearance in 2006.

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 minimally invasive medical 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. Founded in 1963 and operated as a family-held private corporation, 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.


Source: Cook Medical

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