Cook (Bloomington, Indiana) has received FDA pre-market approval to market its Zilver Vascular Stent for use in treating symptomatic vascular disease of the iliac arteries.
The Zilver stent - named for the Z-pattern seen in its architecture - is indicated for use in the treatment of symptomatic vascular disease of the iliac arteries with a reference vessel diameter of 5 mm to 9 mm. The stent, made of nitinol, can be used to treat lesions up to 100 mm in length, according to the FDA approval of indications.
Rob Lyles, global leader of Cook's diagnostic and interventional products division, noted that this type of stent, besides being larger than a coronary stent, does not require a balloon for deployment but uses a sheath and the “shape memory“ of nitinol for placement and to withstand the forces with the iliac vasculature. He told Medial Device Daily that the ability to “get this stent to land exactly where you deploy it - it doesn't jump on you - differentiates the Zilver from the Wallstent from Boston Scientific [Natick, Massachusetts] that is indicated for use in the iliac.“
Lyles said that the company previously has won approval for the vascular indication in 25 countries and that this is the first approval in the U.S. for the vasculature indication.
He emphasized Cook's drive to provide an array of products in several categories - access products, filters, AAA, embolization, balloons and stents - and that the Zilver helps to fill out these lines.
“Cook is driving hard toward peripheral vascular disease, supporting physicians in doing that work. We're pushing that edge forward,“ he said.
Cook's submission to the FDA was supported by data from a 20-patient pilot study and a pivotal study evaluating 151 patients at 24 U.S. investigational sites.
“With this FDA approval, we now have an advanced stent design that can significantly aid patients with this condition,“ said Barry Katzen, MD, medical director of Baptist Cardiac and Vascular Institute (Miami). Katzen was primary investigator for the pivotal U.S. trial of the Zilver stent.
— Don Long, Managing Editor