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Zilver® Vena™ Venous Self-Expanding Stent receives FDA approval to market in the US

Thursday, October 15, 2020

Cook Medical today announced that the Zilver® Vena™ received FDA premarket approval (PMA) in the United States. The product is expected to be commercially available to physicians in the U.S. in Q4 2020.

Zilver Vena is a self-expanding stent approved to treat patients suffering from iliofemoral venous disease. Venous disease is a condition where the body cannot properly pump blood through veins back to the heart. Venous disease affects more than 30 million Americans.1 Although symptoms may vary, this complex condition can severely affect a patient’s quality of life with problems such as leg pain, swelling, and blood clots.2 When implanted in a patient with venous disease, Zilver Vena expands to keep blood flowing through narrow or blocked veins. To receive this FDA premarket approval, Cook Medical had to provide scientific evidence that the device is safe and effective for its intended use in treating venous outflow obstruction.

The stent was designed to balance flexibility and strength: it’s flexible so that it can conform to a patient’s unique anatomy while it provides sufficient lumen expansion to open blocked veins. Zilver Vena is uniquely designed specifically to meet the needs of patients suffering from iliofemoral venous disease.

“We are only in the early stages of understanding this complex disease, but Cook is committed to driving venous therapy development,” said Mark Breedlove, vice president of Cook Medical’s Vascular division. “We are engaged and committed to working alongside physicians and investing in thorough internal training, physician education, building clinical evidence, and more.”

Physician trainings for Zilver Vena will be available soon. Check back for updates on Cook Medical’s Vascular page.

About Cook Medical
Since 1963, Cook Medical has been inventing, manufacturing and delivering a unique portfolio of medical devices to healthcare systems around the world. We work closely with physicians to develop technologies that improve patients’ lives. Because we remain family owned, we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at CookMedical.com, and for the latest news, follow us on Twitter, Facebook and LinkedIn.

1 Gloviczki P, Comerota AJ, Dalsing MC, Eklof BF, Gillespie DL, Gloviczki ML, et al. The care of patients with varicose veins and associated chronic venous disease: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53(5 Suppl):2S-48S.

2 Davies, A.H., 2019. The seriousness of chronic venous disease: a review of real-world evidence. Advances in therapy, 36(1), pp.5-12.

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