March 27, 2019
Cook Medical Launches Zenith Dissection Endovascular System
March 28, 2019—Cook Medical announced that the first patient in the United States was treated in with company's Zenith dissection endovascular system as part of the device's commercial launch. The patient was treated by Joseph Lombardi, MD, Director of the Cooper Aortic Center at Cooper University Health Care in Camden, New Jersey. Dr. Lombardi is the Global Principal Investigator of the STABLE I and STABLE II clinical trials.
In February, the company announced FDA approval for the Zenith dissection endovascular system.
According to Cook Medical, the system provides physicians with a less invasive alternative to open surgery for repair of type B dissections of the descending thoracic aorta. The device consists of a proximal stent graft component and a distal bare stent component.
In the company's press release, Dr. Lombardi commented, “The value in this dissection stent is that it’s pathology-specific, designed just for this disease. As the Principal Investigator, receiving FDA approval is something that I had really looked forward to. It’s really exciting and I think it’s going to make a big impact on how dissection is managed.”