Zenith Thoraco+ Endovascular System Receives FDA Breakthrough Device Designation

Summation

  • 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 built on the strength of the proven Zenith platform and represents a next-generation endovascular graft for the treatment of thoracoabdominal aortic aneurysms.
  • This designation is granted to devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Zenith Thoraco+ Endovascular System (Thoraco+) has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). This designation is granted to devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

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.

“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 vice president of Cook Medical’s Vascular division.

The Thoraco+ is built on the strength of the proven 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. To accommodate varied patient anatomy, the Thoraco+ will be available in a range of diameters and lengths.

To learn more about the Breakthrough Device Designation program, visit the FDA’s website. To learn more about Cook Medical’s aortic intervention products, visit our website.

Other FDA News of Interest

FDA Grants AI-Powered Notal Vision Home OCT “SCANLY” De Novo Marketing Authorization

“We are very excited to receive FDA authorization to market SCANLY Home OCT as the first-ever patient self-operated, home-use device that gives physicians remote access to high-resolution, cross-sectional retinal images and AI-based analytical biomarkers of their patients eyes between office visits,” said Kester Nahen, PhD, CEO of Notal Vision. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”

Atraverse Medical Receives FDA Clearance for HOTWIRE™ Left Heart Access Device, Oversubscribes Seed Round with $12.5M Invested

The HOTWIRE system, invented by Atraverse Medical Co-Founders Dr. Steven Mickelsen and Eric Sauter, introduces a paradigm shift in left-heart access.

RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite

“We are pleased to expand our stroke AI imaging portfolio, the broadest in the industry, to include this new module. With AngioFlow™ by RapidAI, we can now support stroke AI imaging along the entire patient pathway, from the initial non-contrast CT scan all the way to the interventional suite,” said Karim Karti, CEO of RapidAI. “Already registered and used in Japan and Europe, we believe this technology will make a significant difference in the lives of U.S. stroke patients.”

By using this website you agree to accept Medical Device News Magazine Privacy Policy