Cook Medical 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.
According to a company’s press release, this approval 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.
Dierk Scheinert, Medicine director and chairman of the Center for Vascular Medicine, Park Hospital, Leipzig, Germany commented: “For the most effective treatment of peripheral artery disease, physicians worldwide are looking to combination therapy devices. This new balloon from Cook, combining mechanical intervention with a drug, is an excellent percutaneous transluminal angioplasty treatment option as we continue to embrace new therapies to offer our patients.”
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.
The Advance 18 PTX balloon is not available for sale in the United States.