Wednesday, 25 January 2012
Cook Medical Launches the Advance® 18 PTX® Drug-Eluting PTA Balloon Dilatation Catheter for Peripheral Vascular Usage.
Leipzig, 25 January 2012: Cook Medical, a world leader in minimally invasive medical technologies, has launched its first drug-eluting balloon (DEB) approved to treat stenotic or occlusive disease in the peripheral vascular system. The Advance 18 PTX will be sold across Europe following CE Mark approval in December 2011 after notification from Lloyds Register Quality Assurance, London. This approval, which adds to Cook’s leg therapies product range, makes Cook the first medical device manufacturer with regulatory approval to sell both a drug-eluting peripheral stent and a drug-eluting peripheral angioplasty balloon.
Based on Cook’s drug-eluting technology, the Advance 18 PTX combines the benefits of mechanical and drug therapies, taking advantage of the Advance balloon and the anti-proliferative effects of paclitaxel. The proprietary coating process involves no polymers or excipients, and the balloon is coated before being folded, allowing for more drug-to-vessel contact.
Professor Dierk Scheinert , Medicine Director and Chairman of the Center for Vascular Medicine, Park Hospital, Leipzig, Germany comments, “For the most effective treatment of PAD, physicians worldwide are looking to combination therapy devices. This new balloon from Cook, combining mechanical intervention with a drug, is an excellent PTA treatment option as we continue to embrace new therapies to offer our patients.”
The DEB joins Cook’s existing combination therapy device, the Zilver® PTX Drug-Eluting Peripheral Stent that is approved for use in the superficial femoral artery (SFA). Andy Förster, EMEA leader for Cook Medical’s Peripheral Intervention division comments, “We are pleased to offer the Advance 18 PTX to physicians across Europe. The device builds on Cook’s commitment to drug-eluting technologies and we are now able to provide more options in combination leg therapies to treat peripheral arterial disease (PAD).”
Förster adds, “We are seeing a movement by physicians from bare to drug-eluting devices. Cook’s combination stent, Zilver® PTX®, has already overtaken our bare metal business in Europe and we expect our new DEB to also be embraced by physicians who prefer angioplasty in the periphery.”
At present, one in five men aged 50-75 in the UK have peripheral arterial disease (PAD) or peripheral vascular disease, which is caused by atherosclerosis – the build-up of fatty deposits within the lining of the arteries. The most common symptom in people with PAD is leg pain, particularly when exercising. People with PAD have an increased mortality risk and are six to seven times more likely to suffer from heart disease or stroke compared with healthy people.
The Advance 18 PTX is the latest addition to Cook’s leg therapies product range, including the Approach® CTO Microwire Guide, Approach® Hydro ST Microwire Guide and CXI™ Support Catheter along with the Zilver PTX Drug-Eluting Peripheral Stent, Zilver Vena Venous Stent and the Micropuncture Pedal Access Set. Cook’s Advance PTX balloon and Zilver PTX stent are not available for sale in the United States.
About Cook Medical
A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts and cell therapies across more than 16,000 products serving more than 40 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company that has created more than 10,000 jobs worldwide. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter and LinkedIn.
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