World’s first drug-eluting stent for a widespread form of peripheral arterial disease now available throughout the EU.
In a breakthrough development that could dramatically reduce the number of leg amputations and painful bypass graft surgeries performed annually on European patients, a first-of-its kind drug-eluting stent for a widespread form of peripheral arterial disease (PAD) is now available to physicians throughout the European Union.
Cook Medical’s new CE Marked Zilver PTX drug-eluting peripheral stent is widely expected to improve the standard of care for many patients with serious blockages in the superficial femoral artery (SFA) by creating a highly effective, completely new treatment option.
In the largest clinical trial of its kind ever conducted, the Zilver PTX stent was shown to effectively bridge the gap between the patient results achieved using open surgical bypass graft procedure — which is typically more painful and requires a longer hospital stay for the patient – and the less traumatic, but typically less effective, earlier minimally invasive treatment options for PAD such as balloon angioplasty and bare metal stenting, a press release issued by the company said.
“With the Zilver PTX stent, Cook has introduced a true landmark device that can reduce the number of PAD patients having to endure the trauma of leg amputations and bypass surgeries,” explained Rob Lyles, vice president and global leader of Cook Medical’s peripheral intervention unit. “Clinically proven, polymer-free and exceptionally durable, we expect the Zilver PTX stent to become the new standard of care for PAD in the SFA.”
Cook’s revolutionary device will be introduced commercially to European physicians at the annual CIRSE meeting, held this year from 19-23 September in Lisbon. The launch includes several important developments, including the introduction of a new website, http://www.cookmedical.com/zilverptx, with clinical and practical information on the device for patients and physicians in English and major European language languages, and a twitter page for live updates from CIRSE, http://www.twitter.com/ZilverPTX.
Cook also has initiated a first-of-its-kind open clinical database on SFA treatments. The SFA Open-Registry provides physicians with an opportunity to exchange ongoing, real world treatment results. Utilising an intuitive web interface, clinicians may track their patients, view the medical community’s trends in treating PAD and determine the most effective treatment options. Transparency will be a central objective of the SFA Open-Registry, with results for all treatment types available to researchers, regulatory bodies and the public.
Another key breakthrough is Cook’s commitment to a patient-focused strategy that should make the device available to virtually any PAD patient who needs it, Lyles explained. As part of its ongoing corporate mission to help reduce global health care delivery costs, Cook has adopted a unique ‘affordable innovation’ strategy aimed at reducing any potential financial or reimbursement barriers to its widespread adoption as the standard of care for PAD in the SFA.
The first drug-eluting stent approved for treating PAD in the superficial femoral artery (SFA), the difficult-to-treat, largest blood vessel in the leg, the Zilver PTX stent first expands and holds open the artery to restore blood flow. The device then delivers the drug paclitaxel to the cells in the vessel wall to reduce the risk of new blockages forming. In a major advance over previous drug-eluting technologies, the Zilver PTX achieves targeted drug delivery without using a polymer to adhere the drug to the stent body. This eliminates the potential patient risks associated with polymer-coated devices, including clot formation and inflammation.
Cook licenses the rights to use paclitaxel on peripheral stents and other noncoronary medical devices from Angiotech Pharmaceuticals of Vancouver, British Columbia, Canada. In the United States, the Zilver PTX Drug-Eluting Stent is an investigational device not available for sale at this time.
Peripheral arterial disease (PAD), or peripheral vascular disease, is caused by atherosclerosis – the build up of fatty deposits (atheroma) within the lining of the arteries. The most common symptom of PAD is leg pain during exercise. Over time the arteries may narrow due to atherosclerosis, resulting in a reduction in blood flow. Severely reduced blood flow in the limbs is also known as critical limb ischaemia (CLI). It is characterised by leg pain at rest, non-healing wounds and gangrene and may lead to amputation of the limb.