We reported last month on FDA’s approval of the Zilver PTX, the first drug eluting stent cleared in the U.S. for peripheral artery disease (PAD). PAD is a disease of the narrowing of arteries most commonly in the pelvis and legs. According to the National Institutes of Health, about 1 in every 20 Americans over the age of 50 has PAD, and the risk increases with smoking or diabetes. Most cases can be managed by lifestyle changes and medication. However, when vasculature is compromised or symptoms become severe, intervention may be needed.
Cook Medical, a leader in vascular intervention technology, has developed the Zilver PTX as a method to improve PAD intervention. Here at Medgadget we’ve covered the development of the ZIlver PTX over the past 4 years, and last month we also got wind that Cook Medical was announcing a new contract with a leading health care supply chain and contracting company Novation for Cook’s peripheral intervention and peripheral diagnostic devices. We got a chance to speak with Cook Medical Executive VP Rob Lyles about the company’s venturing into peripheral vascular intervention and the Zilver PTX.
Ravi Parikh, MedGadget: What is the current state of the peripheral vascular device market, or lack of? What are the challenges patients with peripheral artery disease face even with medical management?
Rob Lyles: The number of U.S. patients with peripheral arterial disease stands at about 12 million and is expected to increase as baby boomers age and general adverse health conditions, such as diabetes, continue to climb. There is a growing demand for interventional therapies that help patients with PAD return to an active lifestyle, provide relief of symptoms as well as guard against recurring symptoms.
The Zilver PTX is the first drug-eluting stent to treat blockages in a peripheral artery. This is an important advancement as many patients suffer from a re-narrowing of the peripheral artery after treatment and over time. In one study, eight out of ten patients treated with Zilver PTX still had open arteries (primary patency) after one year. That compares to only 3 out of 10 patients treated with angioplasty alone. In addition, patients who received a bare metal stent required more than twice as many reintervention procedures to reopen the SFA as patients who received Zilver PTX.
MedGadget: Where do Cook Medical’s vascular intervention products fit in this environment?
Lyles: Cook is a global leader in the development of medical devices and procedures that have improved the lives of millions of patients and has been the developer of hundreds of medical firsts. The Zilver PTX is the company’s latest example of this.
Cook has focused its efforts since its founding in 1963 on creating new interventional tools and techniques and applying them to patient populations with a need for new treatment options. The Zilver PTX is built on Cook’s proven Zilver stent platform.
MedGadget: Could you tell us where you hope the Zilver PTX will fit in the timeline of care for those with PAD?
Lyles: For some patients, lifestyle changes, medication or exercise can help manage the pain of PAD. Patients with severe PAD might benefit from the Zilver PTX to open blood flow in their legs and to prevent restenosis.
MedGadget: Why did Cook Medical decide to venture into this unique market?
Lyles: Cook is committed to providing treatments for underserved patient populations and for taking proven technologies and applying them to meet physician and patient needs. The combination of Cook’s proven Zilver technology with drug elution that has been successful in coronary artery disease has resulted in a first-of-its kind of solution for patients with PAD. In the U.S., Zilver PTX is the first peripheral vascular device that combines the mechanical support of stenting with the drug paclitaxel to reduce the risk of restenosis.
MedGadget: What stage is the Zilver PTX at in terms of development and clinical trials, and can you share any results?
Lyles: Cook’s Zilver PTX stent is already approved for sale in more than 50 markets, including the European Union, Japan, Brazil and most of South America, Australia, New Zealand and Taiwan.
Two-year data from the Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease indicate that the stent demonstrated 74.8 percent primary patency at 24 months in the PTX group, compared to just 57.8 percent for patients with optimal percutaneous transluminal angioplasty and bare metal stents in the 479 patient study.
We at MedGadget look forward to further advances in peripheral intervention and thank Rob for the interview!
Product Page: Zilver PTX…
Flashbacks: Zilver PTX Drug Eluting Stent Approved for PAD in U.S.; Cook Medical’s Zilver PTX Drug-Eluting Stent Receives Unanimous Recommendation from FDA Advisory Committee; Zilver PTX Drug Eluting Stent for Peripheral Artery Disease Gets European Approval; Cook’s Drug-eluting Peripheral Stent Performs Well in Large Study