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 received CE Mark approval in December , becoming the latest device in the company’s leg therapies product range. It is now 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 technology 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 at Park Hospital in Germany, said of the device: “For the most effective treatment of Peripheral Artery Disease (PAD), physicians worldwide are looking to combination therapy devices. This new balloon, combining mechanical intervention with a drug, is an excellent PTA treatment option as we continue to embrace new therapies to offer our patients.”
This new balloon, 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, which is approved for use in the superficial femoral artery (SFA).
Andy Förster, EMEA leader for Cook Medical’s peripheral intervention division, said of the launch: “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 PAD.”
He added: “We are seeing a movement by physicians from bare to drug-eluting devices. Zilver PTX, has already overtaken our bare metal business in Europe and we expect our new DEB to be embraced by physicians who prefer angioplasty in the periphery.”
We are seeing a movement by physicians from bare to drug-eluting devices
At present, one in five men aged 50-75 in the UK have 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, according to research.