Brisbane, Australia. — Cook Medical’s Zenith® Fenestrated+ Endovascular Graft (ZFEN+) product has received Breakthrough Device designation from the US Food and Drug Administration (FDA). This designation is granted for 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 FDA during the clinical trial and premarket review phases in order to help get lifesaving devices into the hands of physicians more quickly.
‘Cook has continued innovating even through the pandemic, building on years of physician feedback and patient outcomes on our current platform. This Breakthrough Device designation is a sign of our innovation and commitment to providing physicians with options to treat critically ill patients, said Mark Breedlove, vice president of Cook Medical’s Vascular division.
Using technology pioneered and patented in Australia, the ZFEN+ is built on the strength of the proven Zenith platform and represents the next generation of our Zenith Fenestrated AAA Endovascular Graft in the treatment of aortic aneurysms.
‘Qualifying as a breakthrough device is a significant achievement for our in-house R&D team and represents an innovation success story for the Australian medtech industry,’ said Samih Nabulsi, vice president and managing director of Cook Australia. ‘Cook Medical Australia has been at the forefront of endovascular technology since the 90s. This new product has the potential to expand our local manufacturing portfolio and provide increased employment opportunities at our Brisbane facility.’
The ZFEN+ is the first product from Cook Medical to receive a Breakthrough Device designation. Cook is seeking Investigational Device Exemption (IDE) approval from the FDA in the coming months with the intention of beginning a pivotal clinical study later this year. To learn more about the FDA’s Breakthrough Devices program, click here.
About Cook Medical
Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. Headquartered in the United States, we have manufacturing locations in Denmark, Ireland and Australia. We have always remained family-owned so that we have the freedom to focus on what we care about: patients, our employees and our communities.
Cook Medical Australia has more than 600 employees in manufacturing, distribution, engineering and technical specialties. The company exports more than 90% of its locally manufactured products to medical providers worldwide with devices across two product families: endovascular grafts for the treatment of vascular disease and in vitro fertilisation to assist those trying to conceive a child.