FDA Breakthrough Device designation
Cook Medical announced that its Thoraco+ endovascular system has received Breakthrough Device designation from the FDA.
The company describes Thoraco+ as a next- generation, off-the-shelf device in the Zenith platform, indicated for patients with thoracoabdominal aortic aneurysms (Crawford classification I-IV). It has four side branches for the celiac, superior mesenteric, and left and right renal arteries. The device is not
yet commercially available, but Cook notes that the Breakthrough status facilitates priority review and communications with United States regulators during the clinical trial premarket review phases.
“We are excited to receive an FDA Breakthrough Device designation for the Thoraco+.
This will be a great addition to our portfolio of aortic products so we can offer treatments to a wider variety of patients,” commented Mark Breedlove
in the company’s announcement. Mr. Breedlove is Senior Vice President of Cook’s Vascular division.
In Jan. 2022, Cook gained Breakthrough Device designation for its below-the-knee drug-eluting stent, and in 2021, the company’s ZFen+ endovascular graft
was also granted Breakthrough status. VTN