Cook Medical today announced that the Zilver Vena received US Food and Drug Administration (FDA) premarket approval (PMA) in the USA. The product is expected to be commercially available to physicians in the USA in Q4 2020.
Zilver Vena is a self-expanding stent approved to treat patients suffering from iliofemoral venous disease. 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.
According to a press release, the stent was designed to balance flexibility and strength: it is flexible so that it can conform to a patient’s unique anatomy while it provides sufficient lumen expansion to open blocked veins.
“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.”