First drug-eluting stent for femoral artery blockage available in EU

13 October 2009

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 in the European Union.

Created by Cook Medical, the 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 an effective, new treatment option.

In the largest clinical trial of its kind, 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.

“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 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. Utilizing 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 participating physicians.

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 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 stent 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.

In the United States, the Zilver PTX Drug-Eluting Stent is an investigational device not available for sale yet.

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