Munich, Germany – Cook Medical, a world leader in minimally invasive medical technologies, has launched the world’s first-ever stent designed and approved specifically to treat symptomatic iliofemoral venous outflow obstruction. The Zilver Vena Venous Self-Expanding Stent has received CE Mark approval and is now available to physicians across Europe.
“We are proud to launch this important product at CIRSE 2011,” said Andy Förster, EMEA leader of Cook Medical’s Peripheral Intervention division. “This allows Cook Medical to offer physicians and their patients a good option to treat obstructive veins.”
Each year, one in 1000 people will experience venous thromboembolism (VTE) for the first time¹. More than 50 per cent of patients who develop nonfatal VTE will go on to develop post-thrombotic syndrome (symptoms such as skin discoloration, pain and swelling)². This post-thrombotic syndrome results from chronic scarring of the thrombosed veins, resulting in venous outflow obstruction and venous hypertension.
Based on Cook’s existing Zilver technology, Zilver Vena is designed to address many of the challenges of stenting diseased veins, which are very different from diseased arteries. Veins require a stent with strong radial force, good flexibility and large diameters.
Product features:
- Flexible, self-expanding stent made with ’shape memory’ nitinol
- No clinically significant stent foreshortening Available in 14 and 16 mm diameters and 60, 100 and 140 mm lengths to allow precise placement
- Provides consistently strong radial force from end to end
- Incorporates flexibility and kink-resistance of proven Zilver technology
- Compatible with 7 Fr sheaths and 9 Fr guiding catheters
- Deployed via 80 and 120 cm delivery systems
Dr Gerard O’Sullivan³, interventional radiologist at University College Hospital Galway, Ireland, comments:
“There is a significant lack of awareness of modern interventional techniques to remove thrombus and restore venous patency. Until now, physicians who recognise the benefits of venous stenting have been forced to adopt off-label use of stents designed for the arteries. This is challenging because, compared with arteries, veins have less muscle in the wall to keep them open and also have much higher elastic recoil, which tends to close them down unless you use a stent with high radial force.”
Förster comments: “Awareness of venous disease in Europe is increasing thanks to the efforts of governments, associations and industry. This will help more patients to be screened and diagnosed, but awareness of the treatment and prevention options remains low and stenting in the veins currently poses a number of questions for physicians about size and precision. We spent four years developing this product and hope that by taking the guesswork out of venous stenting with the launch of Zilver Vena, more physicians will adopt this type of procedure for treating venous obstruction.”
Förster adds, “Along with embolization products and IVC filters that we already have available for venous disease and prevention, we are developing a full suite of products for deep-vein recanalisation procedures, creating a full venous programme from Cook Medical.”
The Zilver Vena Venous Self-Expanding Stent is an investigational device not approved for sale in the United States.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit . Follow Cook Medical on Twitter @cookmedicalpr.
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¹ White RH. The epidemiology of venous thromboembolism. Circulation. 2003; 107(23)(suppl 1):I4-I8.
² Cohen AT, Agnelli G, Anderson FA, et al. Venous thromboembolism (VTE) in Europe: the number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007;98(4):756-764.
³ Dr. O’Sullivan is a paid consultant to Cook Medical with respect to its medical devices.