Cook Medical today announced that its Zenith Thoraco+ endovascular system received FDA breakthrough device designation.
Thoraco+ is the company’s next-generation endovascular graft that is indicated for the endovascular treatment of patients with thoracoabdominal aortic aneurysms.
“We are excited to receive an FDA breakthrough device designation for the Thoaraco+. This will be a great addition to our portfolio of aortic products so we can offer treatments to a wider variety of patients,” said Mark Breedlove, senior VP of Cook Medical’s vascular division.
Cook Medical’s Thoraco+ endovascular system is an off-the-shelf device that uses four side branches for the celiac artery, superior mesenteric artery, left renal artery and right renal artery. It will also be available in a range of diameters and lengths for various patient anatomies.
Thoraco+ is the second Cook Medical device to receive breakthrough designation in 2022. Its drug eluting stent for below the knee treatment of chronic limb-threatening ischemia won breakthrough designation in January.