In this deal, Cook Medical will take over sales, marketing, and distribution rights for the product in the U.S. The iCast covered stent system will continue to be manufactured by Atrium Medical, a Getinge subsidiary.
“This agreement with Cook Medical ensures that the iCast covered stent system will reach the optimum number of patients who will benefit from it in the United States,” Getinge NA President Patricia Fitch said in a news release. “This distribution agreement allows Getinge to best serve our U.S. market and accelerate our product innovation pipeline, which is in alignment with our global business strategy.”
The iCast covered stent is a clinically evaluated balloon expandable polytetrafluoroethylene-covered stent. It is delivered using a catheter to hold open and support the walls of structures within the body. Renal approval of the device includes 5mm, 6mm and 7mm diameter sizes.
Getinge’s iCast received FDA premarket approval to treat patients with iliac arterial occlusive disease in March 2023.
“This product fills the need of a covered stent in our vascular portfolio with a proven technology. iCast has five-year data aligned with our commitment to long-term clinical evidence and predictable results for PAD Therapies,” said Mark Breedlove, senior VP of Cook Medical’s Vascular division. “Our team is excited to support and distribute the iCast covered stent system across the U.S.”