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Endovascular device for aortic dissection approved, launched
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Cook Medical announced that its endovascular device to repair type B aortic dissections was recently approved by the FDA and was used for the first time commercially in the U.S.
The device (Zenith dissection endovascular system) consists of proximal stent graft and a distal bare stent and is designed to repair type B aortic dissections without open surgery, according to a press release from the company.
“The value in this dissection stent is that it’s pathology-specific, designed just for this disease,” Joseph V. Lombardi, MD, director of the Cooper Aortic Center at Cooper University Health Care in Camden, New Jersey, who performed the first commercial U.S. procedure with the device, said in the release. “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.”
Approval was based in part on the STABLE I and STABLE II trials, in which procedures using the device were associated with low rates of mortality and major adverse events.
Disclosure: Lombardi reports he was global principal investigator of two trials sponsored by Cook Medical and consults for Cook Medical.