Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received Breakthrough Device designation from the Food and Drug Administration (FDA), a press release reports.
The company details that, while the product is not commercially available yet, the benefits of the designation include priority review, and interactive and timely communication with the FDA during the clinical trial and pre-market review phases in order to help get lifesaving devices to patients more quickly.
The Thoraco+ is the second product from Cook Medical to receive a Breakthrough Device designation in 2022. Cook communicates that the device is built on the strength of the Zenith platform and represents a next-generation endovascular graft for the treatment of thoracoabdominal aortic aneurysms. The system is indicated for the endovascular treatment of patients with thoracoabdominal aortic aneurysms (Crawford classification I–IV).
The Thoraco+ is an off-the-shelf device incorporating four side branches for the celiac artery, superior mesenteric artery, left renal artery, and right renal artery. Cook advises that, to accommodate varied patient anatomy, the Thoraco+ will be available in a range of diameters and lengths.
