A Medical Device Daily
William Cook Europe (Bjaeverskov, Denmark), a unit of Cook Medical (Bloomington, Indiana), reported receipt of CE-mark approval for its MiraFlex High Flow Microcatheter.
Engineered to complement the existing offering of Cook embolization products and coils, MiraFlex High Flow embodies, according to Cook, "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 super-selective anatomy for diagnostic and interventional procedures.
Rob Lyles, global leader of Cook's peripheral intervention division, said, "We are ... 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."
Cook says it is the global embolization market leader.
Featuring a .025" inner diameter, MiraFlex High Flow enables optimal coil delivery and can be used in combination with a wide variety of embolization materials, including the top-selling MicroNester and Tornado Microcoils from Cook.
The company said 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 visualization."
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, the company said.
Each MiraFlex catheter 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 was cleared by FDA in 2006.
Progress on two fronts in NHS
The UK Department of Health reports that National Health Service (NHS) staff in England are making "excellent progress" in two key priority areas – to reduce waiting times to 18 weeks and cut Clostridium difficile infections.
Department of Health statistics for August show that nationally the NHS has met its commitment to ensure that 90% of patients who require admission to a hospital and 95% of patients not needing admission, start treatment within 18 weeks of referral from their general practitioner. This means that the operational standard has been met five months ahead of the year-end 2008 deadline, the department said.
The median referral to treatment time waited by patients who were admitted for treatment has come down from 18.8 weeks in March 2007 to eight weeks in August this year and the median referral to treatment time waited by non-admitted patients has fallen from 7.4 weeks in August 2007 to 4.3 weeks in August 2008. And the number of patients waiting longer than six weeks for a diagnostic test has decreased by 97% since April 2006.
In addition, the latest Health Protection Agency quarterly figures – covering the period from April to June 2008 – on C. difficile infections show a big drop in the key over-65 age group, in which cases have dropped by 18% from the previous quarter and 38% since the same quarter in 2007.
Overall, figures show a 21% decrease on the 2007/08 average and mean that the NHS is well on its way to delivering its target, Health Secretary Alan Johnson said,
"Waiting times and infection rates are key priorities for the public and that's why the NHS is focusing its efforts in these areas," he said. "The figures published today are the result of the hard work and dedication of NHS staff and the right investment in resources.
Johnson noted, "Twelve years ago it was common for patients to have to wait two years for an operation and in recent years, C. difficile infections were a significant challenge. Achieving our 18-week commitment nationally five months early is great news for patients in England who can now expect much faster access to NHS care."
CE mark for Bovie's SEER device
Bovie Medical (Melville, New York) reported receiving the CE mark for its SEER tissue resection device intended for initial use in liver oncology surgery, allowing for the sale of the device in the European Union (EU) and all countries recognizing the CE mark.
The company said it would immediately begin shipping the SEER to customers in the EU through its established network of distributors.
Bovie also reported that it had filed a 510(k) pre-market notification application to the FDA requesting U.S. regulatory clearance for the SEER.